AcelRx Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on the development and commercialization of innovative therapies designed for the treatment of acute pain, 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's requirements 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 the FDA has agreed to consider a portion of the Zalviso safety database when reviewing the ARX-04 NDA."
