AcelRx Pharmaceuticals Inc (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies designed for the treatment of acute pain, today reported on the outcome of the ARX-04 (sufentanil sublingual tablet, 30 mcg) pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA). The Company intends to pursue an ARX-04 indication for moderate-to-severe pain in a medically supervised setting. To support this indication, based on feedback from the FDA, the Company will expand the clinical program by approximately 165 patients to include individuals from specific populations and settings. Enrollment in the ongoing SAP302 open-label study in the emergency room will be increased, and a new study known as SAP303 is expected to be initiated in the first quarter of 2016 in postoperative patients with moderate-to-severe pain. SAP303 will focus on enrolling patients greater than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. With these modifications, assuming successful completion of the studies, AcelRx anticipates submitting the NDA for ARX-04 in the second half of 2016
The FDA has also agreed to include, as supporting safety information, data from 323 patients treated in the Zalviso™ (sufentanil sublingual tablet system) clinical studies who had administered two 15 mcg tablets 20-to-25 minutes apart. AcelRx had previously completed and analyzed pharmacokinetic and modeling data, which demonstrated the equivalency of one 30 mcg sublingual sufentanil to two 15 mcg sublingual sufentanil tablets taken 20-to-25 minutes apart.
“Our pre-NDA meeting with the FDA was productive and provided specific guidance for meeting the FDA’srequirements for submitting a New Drug Application for ARX-04,” stated Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx. “Enrollment in the postoperative study (SAP303) is estimated to take three months, and is expected to yield results to help support the NDA submission and review. In addition, we are encouraged that theFDA has agreed to consider a portion of the Zalviso safety database when reviewing the ARX-04 NDA.” (Original Source)
Shares of Acelrx Pharmaceuticals closed last Friday at $4.66, down $0.07 or -1.48%. ACRX has a 1-year high of $9.32 and a 1-year low of $2.92. The stock’s 50-day moving average is $4.80 and its 200-day moving average is $4.18.
On the ratings front, Acelrx Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on October 30, Jefferies Co. analyst Biren Amin assigned a Buy rating on ACRX, with a price target of $7, which implies an upside of 50.2% from current levels. Separately, on October 8, Cowen’s Boris Peaker reiterated a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Biren Amin and Boris Peaker have a total average return of 9.8% and 22.6% respectively. Amin has a success rate of 55.2% and is ranked #347 out of 3618 analysts, while Peaker has a success rate of 47.6% and is ranked #78.
AcelRx Pharmaceuticals Inc is a specialty pharmaceutical company. The Company is engaged in the development and commercialization of therapies for the treatment of acute pain.