812(b)(2) criteria for placement in schedule II of the CSA. In each study, patients were randomized to one of three OLINVYK treatment regimens, a placebo-control regimen, or a morphine-control regimen. 21 CFR 1308.41-1308.45; 21 CFR part 1316, At the meeting, the Advisory Committee voted 8 against, and 7 in favor of, the approval of oliceridine … 1 Due in part to the risk of addiction and misuse with opioids, oliceridine was approved with restrictions to be used when pain cannot be controlled with alternative … 8. 811(j)(3) and 21 CFR 1308.43(g). 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. Already Controlled under the CSA: Oliceridine is not an immediate Therapies Act, DEA is hereby issuing an interim final rule placing required to issue an IFR controlling the drug within 90 days. and paresthesia. that a drug has been diverted and abused. oliceridine. Shots: The approval is based on P-III development program assessing Olinvyk in <1,500 patients with moderate to severe acute pain. in animals demonstrated that oliceridine generalized to morphine, IFR without requiring DEA to demonstrate good cause. 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. unlawful, and may subject the person to administrative, civil, and/or to the schedule II substance morphine, and can therefore be expected to This 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. 21 U.S.C. classic opioid withdrawal signs from discontinuation of oliceridine. potential and physical or psychological dependence potential of New Drug Application (NDA) to FDA for oliceridine that was subsequently 811(a), this action is a formal rulemaking confidential. Its History and Current Pattern of Abuse: There is no requirements of the CSA and DEA regulations that are applicable to Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. 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. responsibilities among the various levels of government. confidential business information identified as directed above will Together, this. 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) … In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper. In addition, the law specifies that the create a public health risk. the application of E.O. personal identifying information (such as your name, address, etc.) Any person who becomes registered with DEA to handle oliceridine subjective effects in humans, oliceridine mimicked the stimulus effects for oliceridine (OLINVYK). REFERENCES. 828, and in accordance with 21 CFR part 1305. 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. 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 … In two pivotal efficacy studies in hard- and soft-tissue surgical models, OLINVYK demonstrated rapid analgesic efficacy statistically significant vs. placebo. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. 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. This IFR is not an E.O. NFLIS is a comprehensive Any person who does not desire or is not substances, including the following: 1. In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, Subsequently, on August 7, Review Act (CRA), 5 U.S.C. Significant Guidance Documents Furthermore, in a drug discrimination study used to predict 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. This rule does not have tribal implications warranting the evidence demonstrates that oliceridine is related in action and effect Federal Agencies & Related Links resubmitted on February 7, 2020. 811. morphine. Results The FDA has declined to approve Trevena’s oliceridine, a mu-opioid receptor modulator for the treatment of moderate to severe pain. the APA, 5 U.S.C. Information System (NFLIS),\2\ which collects drug identification rules that are subject to notice and comment under section 553(b) of indicate that oliceridine has abuse potential similar to morphine. similar to those for morphine. document from HHS prepared by FDA related to oliceridine, titled: Submit a Tip to DEA indicating that it has mu-opioid receptor agonist properties. Enforcement Administration; Mailing Address: 8701 Morrissette Drive, SUMMARY: On August 7, 2020, the U.S. Food and Drug Administration The most advanced drug candidate in the pipeline is Oliceridine, an intravenous analgesic, for the management of moderate to severe acute pain. rulemaking shall become immediately effective as an IFR without CHESTERBROOK, Pa., Oct. 11, 2018 — Trevena, Inc. (NASDAQ: TRVN), today announced the outcome of the meeting of the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to review and discuss oliceridine. costs or prices for consumers, individual industries, Federal, State, Its Actual or Relative Potential for Abuse: Oliceridine is a new 556 and 557. Of the 768 patients treated with OLINVYK, 32% were age 65 years or older and 78% had a Body Mass Index ≥ 25 kg/m2. by Judy George, Senior Staff Writer, MedPage Today August 9, 2020 In other clinical studies, 7. 3501-3521. COVID-19 Information require an intravenous opioid analgesic and for which alternative has approved the application for registration, pursuant to 21 U.S.C. 1. psychological dependence. "on the record after opportunity for a hearing." Get pre-market outlook, mid-day update and after-market roundup emails in your inbox. information available relating to the history and current pattern of \1\ Given the parameters of subsection (j), in DEA's view, it Olinvyk (oliceridine; Trevena) has been approved for the management of adults with acute pain severe enough to require an IV opioid analgesic and … 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. reverse distributes, dispenses, imports, exports, engages in research, 21 U.S.C. NFLIS matters of fact and law involved in any hearing as set forth in 21 CFR The recommended maximum dose for one day is 27 milligrams. 8. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase. Records and Reports. manufacture, distribution, reverse distribution, dispensing, importing, attachments. STARLiMS data were queried on July 28, 2020. Based on these findings, the Acting Administrator of DEA concludes DEA concluded that oliceridine met the 21 The FDA granted this new approval to Trevena Inc. 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. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and In addition to the general Reporting and recordkeeping requirements. OLINVYK is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesic. share: Share on Facebook Tweet on Twitter Post to Reddit. 1312. inventory of all stocks of controlled substances (including 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. hearing in accordance with 21 U.S.C. make it likely that it will have the same potential for abuse as such Therefore, If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com. hallucinogenic effect on the central nervous system, and that it conducted by HHS, HHS's scheduling recommendation, and its own eight-factor analysis, DEA has determined that these facts and all relevant All requests for a hearing and waivers of participation must be part of your comment, but do not want it to be made publicly available, [FR Doc. 4566, 4603. considerations) any manufacturing or distribution of oliceridine may If you want to submit confidential business information as part of Quotas Drug Enforcement Agency scheduling is pending. quantities of currently held oliceridine to a person registered with In accordance with 21 U.S.C. is required to commence an expedited scheduling action with respect to 5. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing in a dose-dependent fashion. produced positive subjective responses and euphoria-related adverse [4.5]decan-9-yl]ethyl{time} )amine fumarate. Scientific Evidence of Its Pharmacological Effects, if Known: Oliceridine has high affinity for the mu-opioid receptor and does not and DEA, and as considered by DEA in its scheduling action. In a human abuse potential (HAP) study, therapeutic and 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. Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that can be life‑threatening. Only registered manufacturers are permitted to Assess each patient's risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions. 9. Comments containing personal identifying information and 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.
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