Amneal Pharmaceuticals has received U.S. FDA approval for its pyridostigmine bromide extended-release tablets indicated for pretreatment against the lethal effects of soman nerve agent poisoning.
The tablets are a once-daily, orally administered product developed for the U.S. Armed Services and U.S. allies. This product offers potential for improved compliance and steady 24-hour release of the drug’s therapeutic benefit, which is intended to provide an alternative to the current pyridostigmine bromide product that is administered every eight hours and avoiding the need for service members to self-administer three times a day.
Pyridostigmine bromide was first approved in 1955 to treat myasthenia gravis, a chronic muscle disease. It was later approved in 2003 for military combat use only, to increase survival after exposure to Soman poisoning, which causes loss of muscle control and death from respiratory failure. The 2003 approval marked the first time a drug was approved under a then-new FDA rule that allowed the agency to rely on animal study data as evidence of effectiveness when studies in humans was not possible.
The new extended release tablets were developed with Amneal’s proprietary GRANDE drug delivery technology, which is an advanced gastric retention system that allows for sustained delivery drug release. The project was funded in part by the U.S. government.
This is the second NDA approval notched by Amneal this year. Back in August, the drugmaker got the FDA nod for a novel oral formulation of carbidopa/levodopa, branded Crexont, for the treatment of Parkinson's disease. Crexont, combines immediate-release granules and extended-release pellets, providing a longer duration of 'good on' time with less frequent dosing compared to the existing immediate-release treatments.