FDA rejects AcelRx's filing for pain therapy Dsuvia; shares plunge

Shares in AcelRx Pharmaceuticals plunged as much as 69 percent Thursday after the company reported that the FDA issued a complete response letter (CRL) regarding a marketing application seeking approval of Dsuvia (sufentanil) for the treatment of pain. "We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA," commented CEO Vincent Angotti.

AcelRx said the FDA provided two recommendations needed for resubmission of the sublingual tablet. The agency noted that while the safety database for the drug was suitable in a 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. Meanwhile, the FDA recommended that to ensure proper administration of the opioid analgesic with the single-dose applicator, certain changes should be made to the directions for use to address use-related errors, including dropped tablets, which should be validated through a human factors study.

AcelRx filed for FDA approval of Dsuvia for the treatment of moderate-to-severe acute pain in a medically supervised setting in December 2016, with the agency accepting the submission in February of this year. The company indicated Thursday that it will request a meeting with the FDA to discuss the CRL, and confirm plans to move towards resubmission of the filing. The therapy, known as ARX-04 outside the US, is currently under review in Europe.

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In 2014, the FDA rejected AcelRx's submission of the patient-activated sublingual analgesic system Zalviso (sufentanil) and requested further information on the drug-dispensing system to ensure proper use of the device. The agency later asked the drugmaker to conduct an additional clinical trial of the system. The European Commission cleared Zalviso in 2015 for the treatment of acute moderate-to-severe post-operative pain in adults.

Earlier this month, RBC Capital Markets analyst Randall Stanicky identified AcelRx as a possible acquisition target if Dsuvia won approval in the US. Meanwhile, the FDA recently declined to approve Intellipharmaceutics' Rexista (oxycodone) and directed the drugmaker to provide additional data confirming the opioid analgesic's abuse-deterrent properties.

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