AcelRx' shares fall after FDA requests new study of Zalviso drug-device combination

Shares in AcelRx Pharmaceuticals fell as much as 40 percent Monday after the company said that the FDA requires a further clinical trial for the resubmission of its filing for Zalviso (sufentanil). The product is a pre-programmed, non-invasive system to allow hospital patients with moderate-to-severe acute pain to self-dose with sublingual sufentanil tablets to manage their pain.

Specifically, AcelRx stated that the FDA asked the company to conduct an additional study to clarify the risk of inadvertent dispensing and overall risk of dispensing failures. The drugmaker noted that it previously received confirmation from the agency that the protocol designs for bench testing evaluating dispensing failures and studies evaluating inadvertent dispensing were acceptable.

The company indicated that it will meet with the FDA to discuss the agency's request and potential study, adding that as a result it will not be submitting the new marketing application this quarter. AcelRx said that additional information regarding the timing of its submission will be provided following its discussions with the regulator.

In July last year, the FDA issued a complete response letter to AcelRx concerning Zalviso and requested additional information on the drug-dispensing system to ensure proper use of the device. The company later estimated that it would resubmit the product to the US agency by the first quarter of this year.

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