June 9, 2019

FDA Reexamines Discontinued Drug for New Pain Applications

The FDA has granted priority review to Orphengesic Forte (aspirin; caffeine, orphenadrine citrate) a combination tablet meant to serve as a non-opioid alternative for the management of pain.

Orphengesic Forte was originally approved in 1998 for the relief of mild-to-moderate pain stemming from acute musculoskeletal disorders; this drug was approved after establishing bioequivalence with Norgesic Forte, a similar product with the same ingredients.

The ingredient orphenadrine citrate is an indirect skeletal muscle relaxant thought to work through central nervous system (CNS) depression, and there is little evidence supporting its use for chronic pain, though it may be helpful in patients with pain related to muscle spasms.

Both Orphengesic Forte and Norgesic Forter were later discontinued for uncertain reasons, but Galt Pharmaceuticals has submitted a Supplemental Abbreviated New Drug Application (SANDA) for Orphengesic Forte for updated pain management indications.

The FDA’s decision to grant the drug priority review will expedite the drug’s review process, indicating that Orphengesic Forte could have the potential to significantly improve the safety or effectiveness of the treatment of pain when compared to standard applications.

Orphengesic Forte has received an application decision date of August 14, 2019. As this drug could potentially find its way into workers’ comp, stakeholders should stay aware of clinical updates surrounding this product.

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