The oral tablets under review by the FDA should be paired with rest, physical therapy and other measures, according to manufacturer Galt Pharmaceuticals.
Officials with the FDA have given Priority Review designation to an opioid-free pain management treatment from Galt Pharmaceuticals.
According to the company, its Supplemental Abbreviated New Drug Application for the orphenadrine citrate, aspirin and caffeine combination (Orphengesic Forte), a muscle relaxant pain reliever, was given an August 2019 goal for approval.
“Health care providers simply need more choices as they look for noncontrolled opioid free alternatives for pain management and our goal is to offer 1 more proven alternative before prescribing an opioid or controlled medication,” said Galt CEO and co-founder Barry Patel, PharmD.
Galt’s request for approval of its combination pain reliever supports the call for opioid addiction prevention by the Center for Medicare and Medicaid Services, according to the company. One of the Center’s key focuses is to manage pain using a safe and effective range of treatment options that rely less on prescription opioids.
Oral tablets containing 50 mg of orphenadrine citrate, 770 mg of aspirin and 60 mg of caffeine, Galt’s combination therapy is indicated for the relief of mild to moderate pain of acute musculoskeletal disorders. The oral tablets should be paired with rest, physical therapy and other measures, according to Galt.
In a prepared statement, the company’s Chairman Wade Smith, PharmD, said Galt believes the ongoing national opioid crisis can be reversed with better practices for pain management, including the availability of nonopioid alternatives.
“Our portfolio will continue to expand with various other nonopioid pain medications in the coming years,” Smith added.
Galt Pharmaceuticals receives FDA Priority Review for non-controlled pain management drug, Orphengesic Forte, an opioid-free alternative for patients [news release]. Atlanta, GA; May 29, 2019: Galt Pharmaceuticals. [email]. Accessed May 29, 2019.