oliceridine fda approval today
Olinvyk (oliceridine) Consumer Information. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. Treatment for: Pain. The efficacy of OLINVYK was established in two randomized, double-blind, placebo- and morphine-controlled studies which enrolled 790 patients with moderate to severe acute pain (pain intensity of ≥4 on a 0-10 numeric rating scale) after orthopedic surgery-bunionectomy or plastic surgery-abdominoplasty. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 69 novel products so far in 2020, including 10 in Aug 2020. CHESTERBROOK, Pa., March 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc., (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine … Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. OLINVYK will be commercially available when the U.S. Drug Enforcement Administration (DEA) issues its controlled substance schedule in approximately 90 days. Proper dosing of OLINVYK is essential, especially when converting patients from another opioid product to avoid overdose. Profound sedation, respiratory depression, coma, and death may result from the concomitant use of OLINVYK with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol). The Company is committed to an ethical and responsible marketing campaign for OLINVYK and will have safeguards in place to monitor for and mitigate the risk of non-medical uses of OLINVYK. Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. by Judy George, Senior Staff Writer, MedPage Today August 9, 2020 WASHINGTON -- Oliceridine (Olinvyk), a novel opioid agonist, won approval to … For more information, please visit www.OLINVYK.com. Of the 768 patients treated with OLINVYK, 32% were age 65 years or older and 78% had a Body Mass Index ≥ 25 kg/m2. Many of these patients are complex and difficult to treat, such as the elderly, obese, or renally-impaired. OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per day were not studied and may increase the risk for QTc interval prolongation. Background. OLINVYK is a new chemical entity approved by the FDA in August 2020. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The FDA’s advisory committee voted 8 to 7 against recommended approval of oliceridine in October 2018, with some panellists expressing concern about adverse events with the drug including QT prolongation, which can indicate an adverse effect on the heart. Manufactured by Pennsylvania-based biopharmaceutical company Trevena, oliceridine was shown in preclinical studies to reduce beta-arrestin-2 recruitment, and … In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS. The Company anticipates that subsequent events and developments may cause the Company’s views to change. Patients using the approved OLINVYK doses of 0.35 and 0.5 mg had a statistically significantly greater SPID-48/24 than patients using placebo. Bolus dosing was initiated at 1 to 2 mg, with supplemental doses of 1 to 3 mg every 1 to 3 hours, as needed, based on individual patient need and previous response to OLINVYK. OLINVYK delivers IV opioid efficacy with a rapid 2-5 minute onset of action. Although one G-protein biased mu-opioid receptor ligand (oliceridine) recently gained FDA approval, knowledge of the possibilities with these compounds has been around for over 20 years. We comply with the HONcode standard for trustworthy health information -, Trevena Resubmits New Drug Application for Oliceridine, Trevena Announces Publication of APOLLO-1 Results in The Journal of Pain Research Highlighting Oliceridine’s Potential for Management of Moderate-to-Severe Acute Pain, Trevena Receives Complete Response Letter for Oliceridine from FDA, Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome, Trevena Announces FDA Acceptance for Review of New Drug Application for Olinvo (oliceridine) Injection, Trevena Announces Submission of New Drug Application to U.S. FDA for Olinvo (oliceridine injection). OLINVYK is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesicOLINVYK product availability expected in fourth quarter of 2020 Company funded through year-end 2021, including OLINVYK commercialization \\--Company to host conference call at 8:30 a.m., today, August 10, 2020\\--CHESTERBROOK, Pa., Aug. 10, 2020 … The Company will host a conference call and webcast with the investment community on August 10, 2020, at 8:30 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Mark Demitrack, M.D., Chief Medical Officer, Robert Yoder, Chief Business Officer, and Barry Shin, Chief Financial Officer. OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Generic name: oliceridine FDA Approved: Yes (First approved August 7, 2020) Brand name: Olinvyk. © 2021 GlobeNewswire, Inc. All Rights Reserved. In patients with circulatory shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac output and blood pressure. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Treatment for: Pain. Additionally, last year in 2019, the US FDA has approved 48 novel … The loading dose for all OLINVYK treatment regimens was 1.5 mg; demand doses were 0.1, 0.35, or 0.5 mg, according to the assigned treatment group; supplemental doses were 0.75 mg. A lockout interval of 6 minutes was used for all PCA regimens. Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving OLINVYK, as they may reduce the analgesic effect and/or precipitate withdrawal symptoms. use in … The FDA granted approval of Olinvyk to Trevena Inc. [2] The DEA issued an interim final rule on October 30, 2020 designating olideridine as CSA Schedule II (DEA Code 9245). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450 (CYP) 2D6 function or normal metabolizers taking moderate or strong CYP2D6 inhibitors; also in patients taking a moderate or strong CYP3A4 inhibitor, in patients with decreased CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. Thursday, October 1, 2020 Oliceridine, a parenterally administered μ-receptor opioid agonist, is approved for the management of moderate to severe acute pain in adults requiring an intravenous (IV) opioid and for whom alternative treatments are inadequate. OLINVYK is contraindicated in patients with: Adverse reactions are described in greater detail in the Prescribing Information. Oliceridine was approved for medical use in the United States in August 2020. “We will work quickly to bring this novel IV analgesic to patients and healthcare providers in need of alternative treatment options.”. Brand name: Olinvyk Following the advisory committee’s 8-7 vote against the approval, the drug was originally rejected by the FDA in late 2018 on grounds of insufficient safety data. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. OLINVYK is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesic, OLINVYK product availability expected in fourth quarter of 2020, Company funded through year-end 2021, including OLINVYK commercialization, Company to host conference call at 8:30 a.m., today, August 10, 2020. The Company also today announced $54.8 million in cash and cash equivalents as of June 30, 2020, which the Company expects will be sufficient to fund operating expenses, including the commercialization of OLINVYK, through year-end 2021. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase. Oliceridine is a full opioid agonist and is … CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved OLINVYK in adults for the management of acute pain severe enough to require an intravenous opioid analgesic … Oliceridine was refused approval by the FDA in November 2018, and the company was asked to submit additional clinical data on QT prolongation and … Current hospital trends suggest that the number of these complex patients is growing, representing an increasing burden on the healthcare system. “The approval of OLINVYK marks an exciting step forward in Trevena’s mission of translating cutting-edge scientific discovery into therapeutic benefit for patients in need. This new medication is found under the name Olinvyk (oliceridine). If confirmed, treat with physiologic replacement doses of corticosteroids and wean patient from the opioid. The US FDA has approved multiple NDAs and BLAs in Aug 2020, leading to treatments for patients and advances in the health care industry. If OLINVYK was administered via PCA, the loading dose was 1.5 mg, the demand dose was 0.5 mg, and the lockout interval was 6 minutes. Previous Name: Olinvo. It is indicated in adults for the management of acute pain severe enough … Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing in a dose-dependent fashion. OLINVYK is a new chemical entity approved by the FDA in August 2020. The US Food and Drug Administration (FDA) has approved the intravenous (IV) opioid oliceridine (Olinvyk) for the management of moderate to severe acute pain … Conference Call to Provide Update Following Recent FDA Approval of OLINVYK, Have not been tolerated, or are not expected to be tolerated. Advise pregnant women using OLINVYK for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. The FDA approved OLINVYK (oliceridine) for the management of acute pain extreme enough to require an IV opioid analgesic in August 2020. Avoid the use of OLINVYK in patients with impaired consciousness or coma. OLINVYK was administered as needed; 55% of patients received OLINVYK via clinician bolus administration only, and 45% of patients received OLINVYK via PCA self-administration or a combination of clinician bolus- and PCA self-administration. The most common (incidence ≥10%) adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia. Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation of a moderate or strong CYP3A4 inhibitor can lower the expected concentration, which may decrease efficacy, and may require supplemental doses. 1-888-info-fda (1-888-463-6332) Contact FDA Subscribe to FDA RSS feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos on Flickr Company: Trevena, Inc. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. I would like to thank all of the patients, investigators, and our employees who helped us achieve this important milestone,” said Carrie L. Bourdow, President and Chief Executive Officer. The most common adverse reactions (≥10%) in these controlled trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia. When stratified by the 27 mg daily dosing limit, discontinuation of OLINVYK due to adverse reactions occurred in 4% of patients who received a daily dose ≤27 mg, and less than 1% of patients who received a daily dose >27 mg. Olinvyk (oliceridine) is an opioid agonist for the management of moderate to severe acute pain in adults. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. With the Aug. 7 approval of oliceridine (Olinvyk, Trevena Inc.) by the FDA, anesthesiologists have a new opioid in their analgesic armamentarium. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration. The Company expects to make OLINVYK available in the fourth quarter of 2020 following scheduling by the DEA, which may take up to 90 days. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. In addition, OLINVYK requires no dosage adjustments in patients with renal impairment, a large patient population with significant medical complications. Risk From Concomitant Use With Benzodiazepines or Other CNS Depressants. A top level FDA official said: “Addressing the opioid crisis remains a top priority for the FDA,” per Dr Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “Complex patients present unique challenges in the management of their postoperative acute pain, due to the presence of medical comorbidities that can complicate dosing,” said Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University. Have not provided adequate analgesia, or are not expected to provide adequate analgesia. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that can be life‑threatening. The FDA approval of OLINVYK was based on results from the Phase 3 development program, which evaluated OLINVYK in over 1,500 patients with moderate to severe acute pain. Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. OLINVYK is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesic. The FDA approval of OLINVYK was based on results from the Phase 3 development program, which evaluated OLINVYK in over 1,500 patients with moderate to severe acute pain. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). A … Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Previous Name: Olinvo Trevena, Inc. TRVN announced that the FDA has accepted its new drug application seeking approval for intravenous (“IV”) oliceridine for management of moderate-to-severe acute pain. Trevena Announces FDA Approval of OLINVYK™ (Oliceridine) Injection. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation. The Food and Drug Administration (FDA) has approved Olinvyk (oliceridine; Trevena) for the management of adults with acute pain severe enough to require … Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. OLINVYK was granted fast track designation for the treatment of moderate-to-severe acute pain in patients by the FDA in December 2015 and breakthrough therapy designation in February 2016. Although self-administration of opioids by patient-controlled analgesia (PCA) may allow each patient to individually titrate to an acceptable level of analgesia, PCA administration has resulted in adverse outcomes and episodes of respiratory depression. Oliceridine is an investigational G protein-selective mu-opioid receptor agonist that has a novel mechanism of action. CHESTERBROOK, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved OLINVYK in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The US Food and Drug Administration (FDA) has approved opioid agonist oliceridine (Olinvyk) for the management of moderate to severe acute pain in adults in instances where pain is severe enough to require an intravenous (IV) opioid.. “OLINVYK represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief, and unique profile.”. CHESTERBROOK, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE)-- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved Olinvyk in adults for the management of acute pain severe enough … Dosage form: Injection FDA Approved: Yes (First approved August 7, 2020) Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. Health care providers and family members monitoring patients receiving PCA analgesia should be instructed in the need for appropriate monitoring for excessive sedation, respiratory depression, or other adverse effects of opioid medications. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. In late 2018, Trevena® was narrowly (eight against: seven for) refused US Food and Drug Administration (FDA) approval for oliceridine (TRV130), but after resubmission the FDA recently approved this new opioid (trade name Olinvyk™) for short-term i.v. Monitor these patients for signs of hypotension. OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Each year, approximately 45 million hospital patients in the United States receive an IV opioid to treat their acute pain. Assess each patient’s risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions. OLINVYK is an opioid agonist that is the first new chemical entity in this IV drug class in decades and offers a differentiated profile that addresses a significant unmet need in the acute pain management landscape. The indication, granted to Trevena, is for short-term IV use in hospitals or other controlled clinical settings including inpatient and outpatient procedures. OLINVYK may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in vulnerable patients. Etodolac 200 mg was available as rescue medication. Investor Contact:Dan FerryManaging DirectorLifeSci Advisors, LLCdaniel@lifesciadvisors.com(617) 430-7576, Company Contact:Bob YoderSVP and Chief Business OfficerTrevena, Inc.(610) 354-8840, Chesterbrook, Pennsylvania, UNITED STATES. In a large, open-label, “real world” safety study, OLINVYK was safe and well-tolerated in a medically complex patient population, including the elderly, obese, and patients with comorbid conditions such as diabetes and sleep apnea. OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. In an open-label safety study of patients with moderate to severe acute pain following a surgical procedure or due to a medical condition, a total of 768 patients received at least one dose of OLINVYK. In two pivotal efficacy studies in hard- and soft-tissue surgical models, OLINVYK demonstrated rapid analgesic efficacy statistically significant vs. placebo. Gradually taper the dosage to avoid a withdrawal syndrome and return of pain. Oliceridine was refused approval by the FDA in November 2018, and the company was asked to submit additional clinical data if it had to be approved. OLINVYK is a new chemical entity indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. Trevena's NDA for Pain Drug Oliceridine Gets FDA Acceptance FDA accepts Trevena's (TRVN) NDA for opioid analgesic, oliceridine, re-submitted last month. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, Known or suspected gastrointestinal obstruction, including paralytic ileus, Known hypersensitivity to oliceridine (e.g., anaphylaxis), OLINVYK contains oliceridine, a Schedule [. Oliceridine (Olinvyk), a new opioid receptor agonist, was approved in the United States on August 7 th, 2020 for the treatment of uncontrolled severe pain that requires an intravenous opioid. OLINVYK should be used with caution in patients who may be susceptible to the intracranial effects of CO. As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in serum amylase. Monitor patients with a history of seizure disorders for worsened seizure control. The FDA approved it to treat adults with moderate to severe acute pain. Olinvyk (oliceridine) is an opioid agonist for the management of moderate to severe acute pain in adults. CHESTERBROOK, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the Company’s partner in China has been approved by the Chinese National Medical Products Administration (NMPA) to initiate … Therefore, the cumulative total daily dose of OLINVYK should not exceed 27 mg. CHESTERBROOK, Pa., March 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV … Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. Supplemental doses of 1 mg were given as needed, taking into account the patient's utilization of PCA demand doses, individual patient need, and previous response to OLINVYK. Select one or more newsletters to continue. In each study, patients were randomized to one of three OLINVYK treatment regimens, a placebo-control regimen, or a morphine-control regimen. Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as recommended, especially in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated patients. Company: Trevena, Inc. Generic name: oliceridine. The most frequent condition treated in the open-label safety study was postsurgical acute pain, and included (in order of decreasing frequency): orthopedic, gynecologic, colorectal, general, plastic, urologic, neurologic (including spinal), bariatric, and cardiothoracic surgical procedures. Available for Android and iOS devices. Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). The FDA approved oliceridine (Olinvyk), a novel centrally acting μ-opioid receptor agonist with reduced β-arrestin recruitment, on August 7, 2020, for managing moderate to severe acute pain in adults who require an intravenous (IV) opioid and for whom alternative treatment is inadequate. Dosage form: Injection. Discontinuation of OLINVYK in this study due to adverse drug reactions occurred in 3% of patients who received a daily dose ≤27 mg and 1% of patients who received a daily dose >27 mg. Full Prescribing Information, including the Boxed Warning, is available at www.OLINVYK.com. FDA approves Olinvyk (oliceridine) for moderate to severe pain (RxWiki News) The US Food and Drug Administration (FDA) has approved a new pain medication to be used in hospitals. A decision is expected in August. OLINVYK was administered via clinician-administered bolus dosing, PCA, or a combination of the two. August 11, 2020 August 11, 2020 - by MyChesCo. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.