- California-based biotech AcelRx on Thursday reported data from a Phase 3 trial showing its experimental opioid painkiller was well-tolerated in managing acute post-operative pain among weakened and elderly patients.
- With positive results in hand, AcelRx plans to submit a new drug application to the Food and Drug Administration by the end of the year.
- Two prior Phase 3 trials showed the drug, called ARX-04, was effective in decreasing pain intensity among adult patients. The Department of Defense has provided funding for development of the drug, hoping it might prove an effective analgesic on the battlefield.
AcelRx stock climbed by nearly 10% in early trading Thursday, boosted by the new, faster timeline towards an application for U.S. approval.
The open-label trial was designed to evaluate the safety of ARX-04 among weaker patients in the post-operative setting. Previous studies had focused on ambulatory patients or those presenting to the emergency room. According to AcelRx, roughly 2 in 3 of the 140 patients enrolled in the study reported no adverse events. For those that did, the most common adverse events were nausea and headache.
The median age of participants in the trial was roughly 55 years although 17% were over 65. Data from older patients is important given the higher risk to morphine and opioid use in that population.
ARX-04 is administered as an under-the-tongue tablet and consists of the synthetic opioid analgesic sufentanil.
In an investor note, Jefferies analyst Hugo Ong pegged "peak potential risk-adjusted sales" at $283 million by 2031 — a modest revenue stream if realized but one very far down the road.
AcelRx has also worked to develop another form of sufentanil called Zalviso, although that hit a roadblock at the FDA when the drugmaker received a complete response letter in 2014.
The drugmaker had nearly $100 million in cash and equivalents at the end of June and estimates it can fund operations through the first half of 2017, according to a filing with the Securities and Exchange Commission. But it noted its existing capital resources would likely be insufficient to fund operations through such a time as it realized enough revenue to sustain itself.