AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)
AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) shares fell 59.8% after the U.S. Food and Drug Administration declined to approve its opioid painkiller Dsuvia. The agency raised a number of issues that the company needs to address pending any future consideration.
One of the recommendations requires AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) to collect additional data on at least 50 patients, assessing the safety of DSUVIA at the maximum amount described in the labeling. The company will also have to ensure proper administration of the tablet with the single dose applicator.
The regulator is also demanding changes to the “Directions for Use” instructions that come with the drug, to address issues of tablets that may need to be disposed of.
The FDA decision rattled investors as most of them were expecting the painkiller to achieve regulatory approval. Analysts were optimistic about the drug gaining regulatory approval on its limited abuse potential. The stock consequently suffered its biggest one-day sell-off since it went public in 2011.
AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) has sought to quash investor concern and prevent a further slide in the stock price by insisting that the recommendations by the FDA are manageable. In a statement, the company says it will request a meeting with the FDA to discuss topics in the Complete Response Letter.
“We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA. We remain focused on the NDA resubmission and our mission to provide physicians and patients with precise and efficient non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings,” said CEO Vincent J. Angotti.
The Chef Executive Officer says they have a sufficient cash runway of $67.9 million to complete the Dsuvia marketing application resubmission. The company also plans to make a marketing submission application for its other drug, Zalviso.
The FDA decision comes at a time when the United States is grappling with a major opioid epidemic. The agency has become cautious in recent years in issuing new approvals on heavy-duty painkillers after more than 33,000 deaths were reported in 2015.
Last month the regulator rejected another opioid painkiller from Intellipharmaceutics as it requested additional data to prove the drug’s ability to prevent abuse.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.