The next key catalyst for AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) is Dsuvia’s Prescription Drug User Fee Act (PDUFA) on October 12, 2017 for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting.

Cowen analyst Boris Peaker points out that given the current opioid abuse epidemic, there is significant uncertainty as to whether regulatory authorities would be comfortable approving a new highly potent opioid.

Peaker noted, “There is significant regulatory risk due to the on-going opioid abuse epidemic which has drawn political attention. While Dsuvia offers a fast on-set of action and sublingual ease of administration, it is also 5-10x more potent than fentanyl and has no abuse deterrent properties outside of limited distribution. Due to the uncertainty associated with potential approval and commercial adoption, the company is minimizing pre-launch expenditures,”

As such, the analyst reiterates a Market Perform rating on Acelrx shares, while no price target was provided. (To watch Peaker’s track record, click here)

Out of the 5 analysts polled in the past 3 months, 3 rate Acelrx stock a Buy, while 2 rate the stock a Hold. With a return potential of 135%, the stock’s consensus target price stands at $8.00. AcelRx shares closed toady at $3.40, down $0.50 or -13%.