FDA Approves New Nonopioid Pain Medication

Officials with the FDA have approved the combination orphenadrine citrate, aspirin, and caffeine 50 mg/770 mg/60 mg (Orphangesic Forte, Galt Pharmaceuticals) for the treatment of patients suffering from mild to moderate pain.

The medication is indicated for the relief of mild to moderate pain caused by acute musculoskeletal disorders, combined with rest, physical therapy, and other measures. According Galt Pharmaceuticals, CDC data has found that 20% of adults in the United States are affected by chronic pain, creating a need for safe, non-addictive treatments.¹

The combination drug had been granted the FDA's priority review status in May 2019.

“Management of pain in the United States is a significant issue impacting quality of life for millions of adults,” said Wade Smith, PharmD, chairman and co-founder of Galt, in a prepared statement.

The new tablets do not directly relax tense muscles, and the mode of action of orphenadrine has not been clearly identified, according to Galt Pharmaceuticals. The combination drug 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.

The adverse events associated with the combination drug are those typically seen with aspirin and caffeine or those associated with mild anticholinergic agents, including tachycardia, palpitation, dry mouth, blurred vision, and pupil dilation.

“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, in a statement.

REFERENCE

Opioid-free pain med orphengesic forte by Galt Pharmceuticals approved by FDA [news release]. Atlanta, GA; July 16, 2020: Galt Pharmaceuticals [email]. Accessed July 16, 2020.