- Shares in Recro Pharma dove more than 50% Thursday morning after the company disclosed receipt of a Complete Response Letter (CRL) from the Food and Drug Administration for its lead candidate, intravenous meloxicam.
- Regulators acknowledged IV meloxicam met the primary goals of late-stage pivotal studies, according to Recro, but ultimately concluded the drug's analgesic effects didn't meet FDA benchmarks. That conclusion stemmed from both ad hoc analyses and selective secondary endpoints.
- Recro, which has been gearing up for approval and launch of the drug, noted there's much ambiguity around the FDA's rejection. "To the best of our understanding right now, there is a lack of clarity in the reviewer's mind about some of the data. And we can't really, until we talk to that reviewer ... provide information or a path forward," Recro CEO Gerri Henwood said during a Thursday morning conference call.
Opioid-based therapies have long dominated the pain management market, in turn fueling the prescription painkiller epidemic currently sweeping through the U.S.
Though there's a push to get more non-opioid options on the market, drugmakers have had trouble clearing the high bar for clinical data set by regulators. Case in point: since 2013 the FDA approved just 10 treatments for pain, half of which have opioids as active pharmaceutical ingredients.
"Many of the novel, non-opioid analgesics are administered as pills. So you get broad systemic exposure, and all you need is one or two serious adverse events or side effects to basically halt the development of your compound," Mike Clayman, CEO of Flexion, told BioPharma Dive earlier this year. In 2017, Flexion received approval for Zilretta (triamcinolone acetonide), a non-opioid drug for osteoarthritis knee pain.
An oral version of meloxicam has been on the market for years, yet it continues to draw interest from manufacturers. Philadelphia-based Iroko Pharmaceuticals in 2016 gained an FDA thumbs up for a low-dose, short-lasting version of the drug, Vivlodex, that it developed using a proprietary fine particle technology.
Regulators weren't so keen on Recro's formulation, however.
During the May 24 call, Henwood said the company is looking to have a meeting with the FDA to iron out whether existing data can address the issues presented in the CRL, or if new trials will be necessary. In the meantime, the fate of meloxicam IV remains uncertain.
That throws a big wrench into company launch plans. On an earnings call earlier this month, Recro's head of commercial John Harlow said the company was planning to send out 53 sales representatives once meloxicam IV secured approval, and would expand that number to 100 sales reps in the following six or so months. At 100 representatives, Recro estimated it could cover 80% of the market opportunity.
Recro also had pricing nearly squared away.
"We've done some extensive and comprehensive pricing work with formulary decision makers, both in the hospital setting, as well as in the ambulatory surgical setting. And we believe that the customer acquisition cost, which would be effective in terms of access, as well as uptake, is going to be in the range of $80 to $100 a day or $80 to $100 per dose," Harlow said on the earnings call.
Those well-laid plans will be on pause, for now at least.
Recro stock, which was trading at a 52-week high of $13.05 per share on Wednesday, opened at a low of $6.01 per share Thursday.