Galt Pharmaceuticals announced FDA approval of Orphengesic Forte (orphenadrine citrate, aspirin, caffeine), to treat acute mild to moderate pain.
Galt announced on July 16 that the company's supplemental abbreviated new drug application for Orphengesic Forte (orphenadrine citrate, aspirin, caffeine, 50 mg/ 770 mg/60 mg) was approved on July 8, more than 2 months ahead of the planned date.
“This is a big win in the fight against the US opioid epidemic and the FDA’s swift early action confirms the seriousness of the issue,” said Barry Patel, PharmD, CEO and co-founder of Galt Pharmaceuticals in the announcement. “Orphengesic Forte is a proven safer pain management alternative healthcare providers can consider before prescribing an opioid.”
Orphengesic Forte is indicated for the relief of mild to moderate pain of acute musculoskeletal disorders, paired with rest, physical therapy, and other measures. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
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 medical community is in great need of alternative therapeutic options to treat pain and Orphengesic Forte helps to meet that need because pain is very personal,” said Tapan Daftari, MD, an orthopedic surgeon with Resurgens Orthopedics, quoted in the Galt announcement.
The side effects of Orphengesic Forte are those seen with aspirin and caffeine or those usually associated with mild anti-cholinergic agents.
Orphengesic Forte is contraindicated in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy, obstructions at the bladder neck, myasthenia gravis, hypersensitivity to the drug, and known sensitivities to aspirin or caffeine.
Galt expects to launch Orphengesic Forte in the second week of August 2020.