Phase 3 of Acute Abdominal Pain Drug Commencing

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AcelRx Pharmaceuticals, Inc. (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today reported dosing of

The first patient has begun a course in a  phase 3 study of a non-invasive, single-use 30 mcg sufentanil sublingual tablet (ARX-04, AcelRx), which has been developed to address moderate-to-severe acute pain following ambulatory abdominal pain.  

The study, SAP301, is a multi-center, double-blind, placebo-controlled study that will evaluate the efficacy and safety of ARX-04 vs. placebo. SAP301 is expected to include approximately 160 adult patients, randomized 2:1 active to placebo, to be treated for up to 48 hours. ARX-04 or placebo will be administered by site staff as requested by the patient, but no more than once per hour. 

"The ARX-04 product represents a promising new application of our sublingual tablet technology for delivery of sufentanil and has the potential to safely provide non-invasive, fast-acting analgesia for patients in acute pain," Pamela Palmer , AcelRx's founder and Chief Medical Officer said in a prepared statement. "We anticipate enrollment to take up to nine months."

Phase 3 of Acute Abdominal Pain Drug Commencing
SAP301 is expected to include approximately 160 adult patients, randomized 2:1 active to placebo, to be treated for up to 48 hours.
 AcelRx, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today reported dosing of the first patient in the pivotal Phase 3 study of ARX-04. This study, SAP301, is a multi-center, double-blind, placebo-controlled study that will evaluate the efficacy and safety of ARX-04 vs.
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