(Adds details on drug, CRL recommendations, shares)
Oct 12 (Reuters) - The U.S. Food and Drug Administration did not approve AcelRx Pharmaceuticals Inc's opioid painkiller in its present form, the company said, sending its shares plunging 57 percent in premarket trading on Thursday.
The decision comes at a time when federal regulators have increased their scrutiny on opioid drugs amid an opioid abuse epidemic in the United States.
The drug, Dsuvia, is a formulation of an opioid drug that is marketed for intravenous delivery, and is meant to be administered orally in patients using AcelRx's proprietary delivery technology.
The FDA, in a complete response letter to AcelRx, requested for additional safety data from the drug in at least 50 patients with acute pain in trauma and ambulatory settings.
The regulator also asked for certain changes to the drug's administration via a single-dose applicator and also recommended updating the directions for use.
About 5.1 million people undergoing out-patient and short-stay in-patient procedures and nearly 8.8 million patients who are treated in-office and in ambulatory surgery centers experience moderate-to-severe acute pain, according to the American Hospital Association.
The Redwood City, California-based drugmaker's shares plunged 57 percent to $3.05 before the bell on Thursday. (Reporting by Manas Mishra in Bengaluru; Editing by Martina D'Couto)