Shares of AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX) surged following positive results from a late-stage trial. The company announced the outcome of an open-label Phase 3 trial (SAP303) of investigational product candidate ARX-04. Let us just say, it made the grade.
The drug was well tolerated in the management of moderate-to-severe acute pain in post-operative study patients, including elderly patients and those with organ impairment. Separately and regardless of age and organ function, approximately two in three patients had no adverse events during the study (63% of all patients, 63% of those aged 65 years or more, 62% of those with hepatic impairment, 70% of those with renal impairment).
On the other hand, the most common adverse events were nausea and headache. On a global assessment of ARX-04 as a method of pain control, 90% of health care professionals and 87% of patients responded on the positive side.
Pamela Palmer, MD, PhD, co-founder and chief medical officer of AcelRx, commented:
Following short-stay in-hospital surgery, post-operative patients who do not require long-term analgesia still need safe and effective short-term pain management for efficient discharge. In the SAP303 trial, I was impressed that the majority of patients—including the majority of higher-risk patients—did not experience any adverse events.
Shares of AcelRx were last trading at $3.60 on Thursday, up 9.7% on the day, with a consensus analyst price target of $6.85 and a 52-week trading range of $2.40 to $5.88.