AcelRx's Opioid Painkiller Dsuvia Gets CRL, Shares Plunge
Zacks Investment Research | Oct 12, 2017 11:05PM ET
AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) plunged nearly 60% after it announced that the FDA has issued a complete response letter (“CRL”) to its new drug application (“NDA”) for Dsuvia. The company is looking to get Dsuvia tablets approved for treating moderate-to-severe acute pain following a trauma or injury or surgical procedures.
The NDA included safety data from two phase III studies, which evaluated 30 mcg Dsuvia tablet administered through the company’s non-invasive single-dose applicator ("SDA").
Shares of AcelRx have fallen 17.4% so far this year, underperforming the industry ’s gain of 0.5% in the period.
The FDA rejected the NDA in its current form providing recommendations especially regarding safety data and drug administration. The FDA has requested for additional safety data on at least 50 more patients dosed at maximum amount proposed for labelling. The regulatory authority has also recommended changes to labelling to ensure proper administration of the tablet.
AcelRx believes that the data requested in the CRL are manageable. The company is planning to request a meeting with the FDA for discussing the issues before confirming resubmission of the NDA.
A marketing authorization application for the pipeline candidate is under review in the EU.
With no approved products, the company’s growth is completely dependent on its success of opioid analgesics pipeline candidates, which include Dsuvia and Zalviso. Zalviso had also received a CRL in 2014. AcelRx completed a study in August required for resubmission of its NDA, which is anticipated this year.
As evident from the Zalviso CRL, the drug approval process has been delayed by three years. The delays certainly affect the company’s prospects and any other setback will pull shares down further.
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