AcelRx puts Zalviso NDA resubmission on hold; shares slammed

 
• By Donna Young
  
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Shares of AcelRx Pharmaceuticals plummeted about 30% on 5 May after the FDA reiterated its earlier demand that a new clinical trial was needed before the company resubmits its new drug application (NDA) for Zalviso, a pre-programmed, non-invasive, handheld system that delivers 15mcg per dose as needed of the opioid sufentanil, allowing hospital patients to self-dose in managing their pain.

Shares of AcelRx Pharmaceuticals plummeted about 30% on 5 May after the FDA reiterated its earlier demand that a new clinical trial was needed before the company resubmits its new drug application (NDA) for Zalviso, a pre-programmed, non-invasive, handheld system that delivers 15mcg per dose as needed of the opioid sufentanil, allowing hospital patients to self-dose in managing their pain.

So AcelRx said it has put its resubmission plans on hold while it seeks input from regulatory, legal and clinical...

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