The Food and Drug Administration (FDA) has approved the supplemental Abbreviated New Drug Application (sANDA) for Orphengesic Forte (orphenadrine citrate, aspirin, caffeine tablets; Galt Pharmaceuticals).
Orphengesic Forte consists of orphenadrine citrate 50mg, aspirin 770mg, and caffeine 60mg in an oral tablet formulation. It is indicated for the symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. The orphenadrine component is also 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.
“Galt acquired Orphengesic Forte in 2017 and submitted a supplemental ANDA to market it to the healthcare community and provide a much needed safer pain management alternative amidst the ongoing opioid crisis,” said CEO and co-founder Barry Patel, PharmD. Several generic equivalents had been previously available up until about a decade ago, however reduced demand led to discontinuations. In a statement, Patel noted that the generics were discontinued for business reasons and not for safety or efficacy issues.
According to the Company, the ANDA had been approved 2 months ahead of the scheduled goal 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,” added Patel.
Because of its anticholinergic effects, Orphengesic Forte is contraindicated in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or bladder neck obstructions. It is also contraindicated in patients with myasthenia gravis or in those with sensitivities to aspirin or caffeine.
The Company expects to launch Orphengesic Forte in the second week of August 2020.
For more information visit galtrx.com.