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.

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. opioid and for patients whose alternative treatments are inadequate. Olinvyk, previously known as Olinvo, was approved on its Aug. 7 PDUFA date.

The opioid agonist is only approved for short-term hospital or other controlled clinical setting use, which includes inpatient and outpatient procedures. The FDA’s maximum recommended daily dose limit is set at 27 mg. High-risk patients – elderly, obese, renally impaired and/or co-morbid – compose the initial target market.

The G protein-biased mu-opioid receptor ligand is designed to enable more selective targeting of newly discovered pathways with few side effects. The label cites a two- to five-minute onset of action, contains no metabolites and requires no dosage adjustments in patients with renal impairments, which Mark Demitrack, Trevena’s senior vice president and medical officer, said is “a significant advantage of this drug compared with others in its class given the prevalence of this medical complication in hospitalized patients.”

Trevena said Olinvyk is expected to be available in the fourth quarter of 2020. On Monday’s conference call with investors, Carrie Bourdow, Trevena’s CEO and director, said she expected DEA scheduling to take about 90 days, placing the launch in mid-November.

Carrie Bourdow, president and CEO, Trevena

“We're not hearing anything that would cause us to comment that it's any different. We've been checking up on that. We've talked to a lot of different sources,” she said. “They don't seem to be impacted at all by COVID. So we think we'll – that 90 days, we think that's pretty firm.”

H.C. Wainwright & Co. analyst Douglas Tsao estimated it will actually creep into 2021, noting Monday that “launching during the holidays would not be productive, even if there are typically a high volume of surgical procedures, though it remains to be seen if COVID-19 affects this normal seasonal pattern.”

Trevena is not providing guidance on Olinvyk’s price other than the $100 price point the company’s market research had previously turned up, Bourdow said.

“Formulary stakeholders indicated that they would put the drug on formulary,” she added. “But now that we have the label in hand, we'll go out and do a little bit more market research and then provide guidance as we get closer to launch.”

Tsao’s model showed peak U.S. sales at $284 million.

The FDA made a point to say Olinvyk’s not for at-home use. Among many of the FDA cautions, Olinvyk will have a warning on the box about addiction, abuse and misuse. Other warnings include life-threatening respiratory depression, neonatal opioid withdrawal symptoms and risks from concomitant use with benzodiazepines or other central nervous system depressants.

The path to approval was lengthy. In early 2017, Trevena reported top-line results from its pivotal phase III APOLLO-1 and -2 efficacy studies with Olinvyk (previously TRV-130) in moderate to severe acute pain following bunionectomy and abdominoplasty (tummy tuck), respectively, showing that all dose regimens across both trials achieved the primary endpoint of statistically greater analgesic efficacy than placebo as measured by responder rate. The candidate also showed dose-related trends of improvements vs. morphine on multiple measures of respiratory safety and gastrointestinal tolerability in acute pain management.

The NDA was submitted in November 2017. In October 2018, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 7-8 against recommending the proposed 0.1-mg and 0.35-mg doses of the opioid. A month later, regulators hit Chesterbrook, Pa.-based Trevena with a CRL, saying they wanted more clinical data on QT prolongation, that the submitted safety database was not big enough for the proposed dosing and more nonclinical data and validation info were needed.

In February 2020, Trevena resubmitted the NDA. The next month saw the FDA set the Aug. 7 PDUFA date.

Trevena’s stock (NASDAQ:TRVN) reacted well to the approval as shares rose 31.5% on Monday to close at $3.13. The stock price has more than doubled in the past 12 months.

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