May 5, 2015
By Alex Keown and Riley McDermid, BioSpace.com Breaking News Staff
REDWOOD CITY, Calif. – The hits keep coming for AcelRx Pharmaceuticals and its lead drug candidate Zalviso, a pain fighting drug-device. Company stock tumbled 27 percent after the U.S. Food and Drug Administration (FDA) rejected the company’s request for a special meeting to discuss safety issues regarding Zalviso.
In addition to the disappointing news regarding its pain treatment system, AcelRx also reported a loss of $10 million for the first quarter which ended March 31. This morning AcelRx’s stock is trading at $3.06 per share, down from Monday’s close of $4.20 per share.
The device has been at the heart of a nearly year-long dispute between the pharmaceutical company and federal regulators. In July the FDA rejected Zalviso’s New Drug Application, citing concern over optical system errors, as well as the shelf life of the painkilling sufentanil tabs the device uses. The rejection caused company stock to crater, as did another correspondence between the company and the FDA in March, when the federal agency said that a human clinical study of the drug/device was required to evaluate the risk of accidental dispensing and the overall risk of dispensing problems. Last week the FDA maintained AcelRx should conduct additional clinical trials to ensure proper safety standards.
Zalviso is a non-invasive device designed for patients to self-administer sublingual tablets of the opioid sufentanil drug, in an attempt to manage their pain without the use of traditional IV systems.
Howie Rosen, the interim chief executive officer for AcelRx, said the company continues to stand behind previous research submitted to the regulatory agency. He said additional clinical studies should not be required to “demonstrate the safety and efficacy of the Zalviso System beyond what has already been established in the Phase 3 clinical studies, as well as the bench testing and Human Factors studies.”
Rosen added the company will provide a further updates on moving forward with the goal of gaining approval to market Zalviso in the U.S. The company said it is consulting with regulatory, clinical and legal advisers to plan its next steps.
“We will be considering all options to determine a pathway forward for Zalviso including the possibility of dispute resolution through one of the FDA prescribed pathways as well as conducting additional clinical or human factors studies,” the company said in a statement.
Rosen said the company will also continue to develop another fast-acting and non-invasive pain treatment system ARX-04 , which has applications for use with the military as well as civilians. The company reported dosing of the first patient in a Phase III trial to evaluate the efficacy and safety of ARX-04. The system is a single-use 30 mcg sufentanil sublingual tablet in a disposable, pre-filled, single-dose applicator.
Will Hungry Pfizer Make a Play for Struggling GlaxoSmithKline?
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