AcelRx Pharmaceuticals is in the doghouse with investors yet again. The latest, 60% hit to AcelRx’s stock price followed another run-in with the FDA, which knocked back a filing for approval of pain drug Dsuvia.
Officials at the regulator issued the CRL after finding fault with the safety database and directions for use included in the application, AcelRx said. The safety database needs results from at least 50 people on the maximum dose to allay the FDA’s concerns. On the directions for use front, the FDA wants AcelRx to address dropped tablets and other use-related errors and run a human factors study to validate its actions.
That is a fairly light list of requests by the standards of earlier brushoffs AcelRx has received from the FDA. AcelRx CEO Vincent Angotti called the FDA’s recommendations “manageable” in a statement outlining his commitment to resubmit the NDA.
Investors were less sanguine about the CRL, wiping about 60% off a stock already battered by the missteps AcelRx has made since the heady days of 2013 and early 2014. Many of those missteps related to Zalviso, another AcelRx product the FDA rejected. In that case, the agency rubbed salt in the wound by refusing AcelRx’s request for a Type B meeting and demanding it run a new study, something the company had previously told investors wouldn’t be necessary.
The silver lining from the latest CRL is that the FDA has only asked for the safety work and human factors study. AcelRx’s filing is based on two double-blind trials that compared Dsuvia to placebo in patients experiencing pain after abdominal surgery or bunionectomy. Dsuvia bested placebo in terms of effect on pain intensity, an outcome that was perhaps to be expected given its active ingredient is more potent than fentanyl.
AcelRx’s twist on the painkiller, sufentanil, lies in its sublingual formulation and accompanying delivery device, which the company thinks make it a better option than intravenous and intramuscular delivery in some circumstances.