Non-Opioid Analgesic Gets FDA’s Priority Review for Pain Management

A supplemental abbreviated New Drug Application has been submitted by Galt Pharmaceuticals for Orphengesic Forte, a combination analgesic that the Company hopes will provide an opioid-free alternative to prescribers and patients.

Orphengesic Forte consists of orphenadrine citrate 50mg, aspirin 770mg, and caffeine 60mg in an oral tablet formulation. It was previously approved for relief of mild to moderate pain of acute musculoskeletal disorders as an adjunct to rest, physical therapy and other measures, before being discontinued. While the mechanism of action of orphenadrine citrate in pain management is unclear, it is believed to have analgesic properties in addition to anticholinergic actions.

The Food and Drug Administration has set a Priority Review goal date of August 14, 2019.

“Our healthcare providers are challenged by meeting the individual patient needs in pain management, while trying to avoid using opioids and other controlled substances,” said Snehal Doshi, PharmD, VP of Pharmacy Services at one of Georgia’s largest health systems. “We absolutely need more choices for them to try and we are glad to see a proven analgesic coming to the market.”

For more information visit Galtrx.com.