Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures. It is not indicated for at-home use.
"Addressing the opioid crisis remains a top priority for the FDA. We will continue to do everything we can to reduce the number of Americans who are addicted to opioids and cut the rate of new addiction through a number of cross-agency initiatives," said Douglas Throckmorton M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "Importantly, the FDA will only approve new drug applications, including those for opioid medications, following a rigorous review to evaluate the risks and benefits and ultimate determination that the data support safety and effectiveness. Of note, this particular medication is only indicated for use in a controlled clinical setting, meaning under medical supervision and not for use in a take-home prescription."
More on Marylandian
- Xometry To Let Customers Offset Carbon Generated by Their Orders
- Local Community Health Center Announces New Chief Medical Officer
- Alpine Air Products — Your One-Stop-Shop For All Your Indoor Air Purification Needs
- Meeting Notice: Maryland Spay and Neuter Advisory Board to Meet Oct. 9
- Utopia p2p Releases CRP (Crypton) cryptocurrency on Crypto Exchanges
A total of 1,535 patients with moderate to severe acute pain were treated with Olinvyk in controlled and open-label trials. Its safety and efficacy were established by comparing Olinvyk to placebo in randomized, controlled studies of patients who had undergone bunion surgery or abdominal surgery. Patients administered Olinvyk reported decreased pain compared to placebo at the approved doses.
The safety profile of Olinvyk is similar to other opioids. As with other opioids, the most common side effects of Olinvyk are nausea, vomiting, dizziness, headache and constipation. Olinvyk should not be given to patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction; or known hypersensitivity to the drug. Prolonged use of opioid analgesics during pregnancy can result in neonatal opioid withdrawal syndrome.
Olinvyk carries a boxed warning about addiction, abuse and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other central nervous system depressants. Unlike other opioids for intravenous administration, Olinvyk has a maximum recommended daily dose limit of 27 milligrams.
More on Marylandian
- Pioneer Bank Opts for Indoor Air Quality Upgrades Amid Pandemic Concerns
- Aiming for No Less than Success: 30 Organizations that are Boosting African American Educational Achievement
- CEO Coaching International Provides Clients Value through Powerful Weekly Virtual Networking Events on Zoom
- Brookside Equity Partners Makes Minority Investment in Advanced Solutions International (ASI)
- OncoBeta GmbH and Australian Nuclear Science and Technology Organisation sign Letter of Intent to establish manufacturing site in Australia
The FDA granted approval of Olinvyk to Trevena, Inc.
Media Contact: Nathan Arnold, 301-796-6248
Consumer Inquiries: Email or 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
Filed Under: Business
Latest on Marylandian
- NCBW METRO New York Hosting Virtual Charter Ceremony
- Vision Centre-Ville et ID Gatineau s'associent à Macadamian afin d'offrir une application mobile aux tenanciers de bars et restaurants de Gatineau
- Be The Generation with Representation
- CMS Now Requires Health Care Workers to Receive Access to Long Term Care Facility Patients to Improve Resident Outcomes, Reports the Polaris Group
- Hip Hop Artist C.Y.B. is Slated to Release His New Album Called, "Today We Ready."
- FDA Launches the Digital Health Center of Excellence
- Accurate Rubber Corporation is Proud to Announce ISO 9001:2015 Certification
- Visit Potter-Tioga State Parks Recognized as 'Most Beautiful Fall Foliage' in Pennsylvania
- Nous Imaging Receives 510(k) Clearance from FDA for FIRMM Software
- Evolve IP Enhances Its Microsoft Teams and Cisco Voice Direct Routing Platform
- SCLogic Announces European Expansion
- Nutter Home Loans and Tamara Day Announce Alliance
- Global Leader in Dock and Yard Management Solutions Releases its Latest White Paper, The Paperless Pandemic: How Ditching Documents Keeps People Safe
- The Nation's Leading Chiropractor Announces First Cutting-Edge Facility in Pennsylvania
- International Spy Reveals Secret Past/Future Concerns
- Islamic Leadership Institute of America Hosts Advocacy and Public Policy Graduation
- Community First Health Plans Announces Theresa Scepanski as President and Chief Executive Officer
- AUA College of Medicine Partners with Fisk University
- Permian Museum Adds Gallery of Unknown Life Forms
- U.S. Justice Department, SEC, IRS and Judges Discuss Cross-Border Fraud Litigation at Virtual Fraud, Asset Tracing & Recovery Forum Next Month