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. After suffering multiple setbacks in the past couple of years, Trevena Inc. has a reason to be optimistic about its lead drug. At the meeting, the Advisory Committee voted 8 against, and 7 in favor of, the approval … Current hospital trends suggest that the number of these complex patients is growing, representing an increasing burden on the healthcare system. Each year, approximately 45 million hospital patients in the United States receive an IV opioid to treat their acute pain. Monitor these patients for signs of hypotension. OLINVYK is a new chemical entity approved by the FDA in August 2020. Trevena opioid painkiller fails to win FDA approval, shares plunge. Risk From Concomitant Use With Benzodiazepines or Other CNS Depressants. 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. Have not provided adequate analgesia, or are not expected to provide adequate analgesia. If confirmed, treat with physiologic replacement doses of corticosteroids and wean patient from the opioid. Because of all these positives, the manufacturing deal set in place & the FDA approval pending, for me, i feel it is worth taking a bet on, which is what I am going to do Branded Olinvyk, the drug received agency approval for managing moderate to severe acute pain in adults when the pain is severe enough to require an I.V. TRVN touched a new 52-week high of $2.39 in intraday trading yesterday (Jul.28), before closing at $2.27, up 5.58%. In each study, patients were randomized to one of three OLINVYK treatment regimens, a placebo-control regimen, or a morphine-control regimen. 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. Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Each year, approximately 45 million hospital patients in the United States receive an IV opioid to treat their acute pain. Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that can be life‑threatening. OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. The treatment has been approved for adult patiemtns dealing with acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments simply don’t work. Trevena Inc (NASDAQ: TRVN) has a tryst with the FDA, with respect to its NDA for its pain drug oleceridine, which was once rejected by the agency on the premise of … Trevena NASDAQ Updated Feb 24, 2021 12:00 AM. Summary. Trevena is a biopharmaceutical company focused on the development of novel medicines for patients with central nervous system conditions. On Jan. 2, the FDA accepted Trevena’s NDA for opioid Olinvo; market reaction to the acceptance was muted. 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. If confirmed, treat with physiologic replacement doses of corticosteroids and wean patient from the opioid. Summary. Trevena is a biopharmaceutical company focused on the development of novel medicines for patients with central nervous system conditions. 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). 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. 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 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. 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. “OLINVYK represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief, and unique profile.”. OLINVYK delivers IV opioid efficacy with a rapid 2-5 minute onset 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. Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Over the last three months, the share price of Trevena has gained over 230%. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Assess each patient’s risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions. 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. Start finding winning trades in minutes with Trade Ideas!. “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. Many of these patients are complex and difficult to treat, such as the elderly, obese, or renally-impaired. The most common (incidence ≥10%) adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia. TRVN Stock Is Climbing On FDA Approval Gradually taper the dosage to avoid a withdrawal syndrome and return of pain. FDA committee weighs new Johnson & Johnson vaccine, the House will vote on Biden's $1.9 trillion COVID-19 relief package and more news to start your Friday. OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. 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. Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). 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 … The most common adverse reactions (≥10%) in these controlled trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia. Assess each patient’s risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions. 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 … 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 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 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. 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. In two pivotal efficacy studies in hard- and soft-tissue surgical models, OLINVYK demonstrated rapid analgesic efficacy statistically significant vs. placebo. In two pivotal efficacy studies in hard- and soft-tissue surgical models, OLINVYK demonstrated rapid analgesic efficacy statistically significant vs. placebo. Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. Risk From Concomitant Use With Benzodiazepines or Other CNS Depressants. OLINVYK will be commercially available when the U.S. Drug Enforcement Administration (DEA) issues its controlled substance schedule in approximately 90 days. 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 … Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Trevena opioid painkiller fails to win FDA approval, shares plunge TOPICS: Biotechnology and Medical Research (TRBC) Company News Content produced in Bangalore FDA Health / Medicine Healthcare (TRBC) Medical Regulatory Issues Pharmaceuticals and Medical Research (TRBC) TREVENA United States US In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper. The FDA granted approval of Olinvyk to Trevena Inc. 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 … “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. 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. For more information, please visit www.OLINVYK.com. 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. 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. 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. Etodolac 200 mg was available as rescue medication. Alcami, a US-based contract development and manufacturing organization, announced today that it is providing commercial manufacturing services for Trevena’s newly approved OLINVYK. Therefore, the cumulative total daily dose of OLINVYK should not exceed 27 mg. In each study, patients were randomized to one of three OLINVYK treatment regimens, a placebo-control regimen, or a morphine-control regimen. opioid and for patients … OLINVYK (oliceridine) injection is a n opioid approved in adults for the management of acute pain severe enough to requ ire an intravenous opioid analgesic.Alcami has provided development … Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status. Here’s what’s going on: Stop wasting your time! Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. 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. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase. 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. Trevena believes that there is a major need for a product like Olinvyk, which is a well-tolerated analgesic, in order to help in the management of moderate to severe main in patients. Trevena (NASDAQ:TRVN) +51.2% after-hours, as the Food and Drug Administration approves Olinvyk (oliceridine), an opioid agonist for the management of … 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. Tiny Trevena may have a new lease on life for its controversial opioid painkiller -- rejected by the FDA last November citing the dearth of drug safety data -- … 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 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. 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. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. The company resubmitted the New Drug Application (NDA) to the FDA and it was accepted for review on February 10, 2020. 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. OLINVYK was administered via clinician-administered bolus dosing, PCA, or a combination of the two. In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper. Investor Contact:Dan FerryManaging DirectorLifeSci Advisors, LLCdaniel@lifesciadvisors.com(617) 430-7576, Company Contact:Bob YoderSVP and Chief Business OfficerTrevena, Inc.(610) 354-8840, https://www.trevena.com/investors/events-presentations/ir-calendar, Conference Call to Provide Update Following Recent FDA Approval of OLINVYK, Have not been tolerated, or are not expected to be tolerated. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. The most advanced drug candidate in the pipeline is Oliceridine, an intravenous analgesic, for the management of moderate to severe acute pain. “We will work quickly to bring this novel IV analgesic to patients and healthcare providers in need of alternative treatment options.”. The FDA said in granting approval: “Addressing the opioid crisis remains a top priority for the FDA. 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. The company’s drug, Olinvyk, has been approved for adults for the management of acute pain that requires an intravenous opioid analgesic. Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. 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TRVN touched a new 52-week high of $2.39 in intraday trading yesterday (Jul.28), before closing at $2.27, up 5.58%. admin 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. 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. GlobeNewswire. 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 [. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. 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. 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). Biogen Inc.’s experimental Alzheimer’s disease treatment aducanumab was granted priority review status by U.S. regulators, a move that could hasten the drug’s arrival on the market. Knocked back by a complete response letter (CRL) in late 2018, Trevena Inc. dusted itself off, resubmitted its NDA for oliceridine and found satisfaction as the FDA has approved the opioid agonist. OLINVYK delivers IV opioid efficacy with a rapid 2-5 minute onset of action. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. 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. Of the 768 patients treated with OLINVYK, 32% were age 65 years or older and 78% had a Body Mass Index ≥ 25 kg/m2. Trevena’s Oliceridine for Moderate-to-Severe Acute Pain. 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. 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. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase. Trevena (NASDAQ:TRVN) +51.2% after-hours, as the Food and Drug Administration approves Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid. 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. 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. 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. 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. Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month).