AcelRx post-operative pain treatment meets late-stage study goal
(Reuters) - AcelRx Pharmaceuticals Inc said its experimental drug-device combination to manage post-operative pain met the main goal of a late-stage study on patients who have undergone major open abdominal surgery.
The Redwood City, California company's shares jumped 10 percent to $5.49 after the bell on Monday.
The top-line results, reported from a 178-patient study of AcelRx's Sufentanil NanoTab patient-controlled analgesia (PCA) system, showed that the drug-device combination helped reduce pain significantly compared with a placebo, the company said.
Patients in the study were treated with AcelRx's system for post-operative pain for a minimum of 48 hours and up to 72 hours.
With the handheld NanoTab PCA system, AcelRx is seeking to win approval for a non-invasive way for patients to self-dose the FDA-approved pain drug sufentanil.
Opioids such as morphine that are currently used in the standard treatment, intravenous PCA, can cause side-effects such as nausea and vomiting, and also carry the risk of causing addiction.
Monday's data follows results released in November, that showed the NanoTab system was at least as effective as the standard therapy.
Since then, AcelRx stock is up more than 26 percent to its Monday close.
The company on Monday said it expects to report top-line results from another placebo-controlled, 400-patient late-stage study of the NanoTab system in the second quarter of this year.
(Reporting by Zeba Siddiqui in Bangalore; Editing by Roshni Menon and Andrew Hay)