AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) disclosed that its investigational product candidate ARX-04 provided solid
tolerance level in an open-label Phase three trial for post operative acute pain treatment. This included elderly patients, as well
as, organ impairment.
AcelRX indicated it plans to file for NDA this year following the completion of phase three program on ARX-04. The company
pointed out that about two out of three patients had no adverse events in the trial irrespective of age and organ function. The
most regular adverse events were headache and nausea.
As a method of pain control, the company indicated that 90 percent professionals responded with "good" assessment while 87
percent of patients responded with "excellent."
AcelRx co-founder and Chief Medical Officer, Pamela Palmer, said, "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."
The company indicated that both primary and secondary efficacy endpoints demonstrated a drop in intensity of pain starting at 30
minutes after the first dose.
The stock jumped $0.72, or 21.95 percent, to $4.00 in pre-market trading.
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