AcelRx clawed back another piece of its shattered market cap this morning after declaring a success with its last late-stage study of the powerful pain med sufentanil, delivered under the tongue. And the biotech $ACRX says it’s now ready to hustle back to the FDA for its marketing pitch, 18 months after it was handed a major setback on its lead pain program.
On high alert for problems presented by addictive opioids, AcelRx says the FDA wanted the biotech to recruit patients for a post-operative study that looked at how well patients did in managing their pain with this new sublingual approach to self-administration. And the company gave itself a clean bill of health, saying that a little more than a third of the patients suffered an adverse event — with most of the problems linked to nausea and headache.
A few weeks ago the biotech touted a drop in pain scores for its second small cohort of patients in a study that examined how patients in the ER responded to the pain med. And investigators say they tracked similar reductions in pain scores among the 140 patients in the study.
That will give it all the data it needs to go to the FDA for an approval, says the biotech. Investors bought into that pitch this morning, driving up shares by 22%. The stock, though, is still trading at a fraction of its old levels.
AcelRx has been slowly winning back market support after the company was forced to renege on its promise to investors in early 2015 that it would not need to run another study on Zalviso, the lead pain therapy. That’s exactly what the FDA did require, though, triggering a meltdown in its stock price.
Like ARX-04, Zalviso offers a twist on dosing the powerful opioid sufentanil. It is supposed to allow hospital patients to self-administer micro tablets of the drug under the tongue, replacing an IV, for lightning fast pain relief. The setback last year forced the company to restructure and reconfigure its commercialization plans. Its CEO at the time left soon after.
In a statement, Pamela Palmer, the co-founder and CMO at AcelRx, noted:
“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.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 35,600+ biopharma pros who read Endpoints News by email every day.Free Subscription