Recro Pharma Inc
Benzinga recently had the chance to speak with CEO Geraldine A. Henwood, Ph.D., who shared some insight into the business.
“We are very excited about the results,” the exec commented. “We now are in the position, we believe, to have the efficacy part of our New Drug Application (NDA) in hand [...] We will be supplementing that with some post-filing studies that we’ll be doing to address specific economic issues in the marketplace as well.”
“We thought the safety profile remained excellent for the product,” she added.
The study in question met not only its primary endpoint of statistically significant reduction in SPID24, but also 10 other secondary endpoints. When asked about the endpoints that were not reached, Henwood explained, “The only one that I would’ve liked to have seen a hit, and which was trending in the right direction, but which did not hit statistical significance was the six-hour [endpoint]. You will notice that we did hit time-to-perceptible-pain-relief, and got significance on that, which gives you an idea that patients’ own assessment of how quickly the product works, but we did not hit the SPID6, and I think that is due to this higher placebo response [similar to the SPID12 case] and early use of rescue.”
“I’m particularly happy to see that we did get good value for the percent of patients with greater that, or equal to 30 percent improvement,” she concluded. “Most pain specialists will say that if you can get a patient to that degree of improvement, they are feeling remarkably more comfortable.”
The FDA wants to see that a drug can manage both soft and hard tissue pain, Henwood went on to explicate. “So, we would expect to be able to be used not only for
There’s a large number of patients that could benefit from meloxicam not being an opioid and having no narcotic characteristics that slow down bowel activity, the chief executive added. “So, you can give somebody a dose of this before they left the hospital and you’d have them pretty well covered for the next 24 hours for pain [...] until they are able to take other oral medications.”
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