Officers with the FDA have given Priority Evaluation designation to an opioid-free ache management therapy from Galt Pharmaceuticals.
Based on the corporate, its Supplemental Abbreviated New Drug Application for the orphenadrine citrate, aspirin, and caffeine combination (Orphengesic Forte), a muscle relaxant ache reliever, was given an August 2019 aim for approval.
“Health care suppliers merely want extra choices as they search for noncontrolled opioid-free alternate options for ache management and our objective is to offer one more confirmed alternative before prescribing an opioid or managed medication,” mentioned Galt CEO and co-founder Barry Patel, PharmD.
Galt’s application for approval of its combination ache reliever helps the decision for opioid habit prevention by the Facility for Medicare and Medicaid Services, in accordance with the corporate. One of the Center’s critical focuses is to control ache utilizing a protected and efficient range of therapy choices that rely much less on prescription opioids.
Oral tablets having 50 mg of orphenadrine citrate, 770 mg of aspirin, and 60 mg of caffeine, Galt’s combination remedy is meant for the relief of delicate to the moderate ache of acute musculoskeletal problems. The oral tablets ought to be paired with relaxation, bodily therapy, and different measures, according to Galt.
In a prepared assertion, the corporate’s Chairman Wade Smith, PharmD, mentioned Galt believes the ongoing national opioid disaster will be reversed with higher practices for ache management, along with the provision of nonopioid options.
“Our portfolio will proceed to broaden with various nonopioid ache drugs in the coming years,” Smith added.