=AcelRx Pharmaceuticals (ACRX) : opioid painkiller DSUVIA to be approved by FDA

• AcelRx confirms FDA Advisory Committee voted 10-3 in favor of recommending the approval of DSUVIA for the treatment of moderate-to-severe acute pain in adult patients

FDA staff had said the company's opioid painkiller was safe and effective for use based on resubmitted data. An advisory panel to the FDA will vote on the drug on Friday, before the regulator’s final decision by Nov 3. The staff reviewers are still concerned over the risk of accidental exposure due to misplaced tablets. The FDA's Anesthetic and Analgesic Drug Products Advisory Committee is evaluating the company's new drug application for Dsuvia. The committee said the dosage regimen appear effective in the drug's proposed population and reasonably safe in the context of existing opioid therapy.

=AcelRx Pharmaceuticals (ACRX): Complete Response Letter from the FDA regarding its New Drug Application for DSUVIA

AcelRx receives Complete Response Letter from the FDA regarding its New Drug Application for DSUVIA, 30 mcg

The CRL states that the FDA determined it cannot approve the NDA in its present form and provides recommendations needed for resubmission. The two primary recommendations within the CRL are: first, while the safety database was suitable in number of patients, the collection of additional data was requested on at least 50 patients to assess the safety of DSUVIA dosed at the maximum amount described in the proposed labelling; second, to ensure proper administration of the tablet with the single-dose applicator, the FDA recommended certain changes to the Directions for Use to address use-related errors, including dropped tablets, to be validated through a human factors study.

• AcelRx will request a meeting with the FDA to discuss the topics covered in the CRL, and confirm plans to move towards resubmission of the DSUVIA NDA. AcelRx ended the third quarter with an estimated $67.9 million in cash and we will provide further financial updates on our third quarter earnings call.