New generic version of Mestinon as oral syrup available in U.S.
Therapy works to improve patients' muscle strength, ease MG symptoms
A new generic formulation of pyridostigmine bromide — a muscle-strengthening medication sold under the brand name Mestinon — is now available for people with myasthenia gravis (MG) in the U.S.
This generic, which like the name-brand therapy is available as an oral syrup at a dose strength of 60 mg/5 mL, is commercialized by A.forall through its subsidiary Milla Pharmaceuticals, in partnership with Alora Pharmaceuticals through its subsidiary Acella Pharmaceuticals.
This marks the fourth product launched in the U.S. by A.forall, a Belgium-based company aiming to make more affordable medications, including generics, more widely available.
Mestinon has been used to treat myasthenia gravis since the 1950s
“This fourth U.S. launch is the next big milestone for our group in 2023, which was already a very successful year for us,” Filip Van de Vliet, CEO of A.forall, said in a company press release.
“This product continues our long tradition of supplying affordable generic formulations and furthers our commitment to neurology,” added Art Deas, CEO of Alora.
MG is caused by antibodies that interfere with the signaling between nerve and muscle cells. Normally, nerve cells release a chemical messenger called acetylcholine, which prompts muscle cells to contract. MG-causing antibodies interfere with this process; the most common MG-causing antibodies block protein receptors that muscle cells use to detect acetylcholine. This ultimately results in such disease symptoms as muscle weakness.
Mestinon, which has been approved to help treat MG since the 1950s, works to boost levels of acetylcholine by blocking the activity of an enzyme that normally destroys acetylcholine. By raising levels of this chemical messenger, the therapy can help to improve muscle strength and ease symptoms of MG.
Brand-name Mestinon is currently sold by Bausch Health. Several other generic formulations of the therapy have previously been approved and, like Mestinon, are available in oral (as either syrup or tablets) and injectable forms.
Generics are medications that contain identical active ingredients to name-brand medications, so they may be used interchangeably.
Generics are typically cheaper than their name-brand counterparts, and since they introduce more competition into the pharmaceutical marketplace, they can help to drive down costs overall. The price of the new generic pyridostigmine bromide syrup was not specified.