SILVER SPRING, Md.,
Aug. 7, 2020 /PRNewswire/ -- Today,
the U.S. Food and Drug Administration approved 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 and for whom alternative treatments
are inadequate.
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."
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.
The FDA granted approval of Olinvyk to Trevena, Inc.
Additional Resources:
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.
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SOURCE U.S. Food and Drug Administration