Amneal's Pyridostigmine Bromide Extended-Release Tablets Receive FDA Approval for Nerve Agent Pretreatment
Key Insights
Amneal Pharmaceuticals secures FDA approval for its Pyridostigmine Bromide Extended-Release (PB ER) Tablets, a once-daily pretreatment for soman nerve agent poisoning (search).
The new PB ER tablets offer a 24-hour therapeutic benefit, improving compliance compared to the current three-times-daily regimen.
Developed using Amneal's GRANDE® drug delivery technology, PB ER is designed for the U.S. Armed Services and allies.
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) has received FDA approval for its New Drug Application for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg. This once-daily, orally administered product is indicated for pretreatment against the lethal effects of soman nerve agent poisoning (search) in adults, primarily developed for the U.S. Armed Services and its allies.
Improved Compliance and Sustained Release
The PB ER 105 mg tablets offer a significant advantage over the existing pyridostigmine bromide product, which requires administration every eight hours. The extended-release formulation provides a steady 24-hour release of the drug's therapeutic benefit, potentially improving compliance among service members who would otherwise need to self-administer the medication three times a day.
GRANDE® Technology
The development of PB ER leverages Amneal's GRANDE® drug delivery technology, an advanced gastric retention system that ensures sustained drug release. This project was partially funded by the U.S. government under Agreement W911QY-21-9-0018.
Executive Perspective
"Amneal is proud to receive our second NDA approval this year, after the recent approval of CREXONT for Parkinson’s disease (search). This new pyridostigmine therapy speaks to Amneal’s expertise in developing new innovative product formulations and our ongoing work with the U.S. government on new solutions. With the approval of pyridostigmine bromide extended-release tablets, we are proudly supporting the U.S. military," said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.
Adverse Reactions
The most frequently reported serious adverse reactions in clinical trials included breathing difficulties, dizziness, and loss of consciousness. Other adverse reactions observed were dysmenorrhea, nosebleeds, reduced vision in one eye, and decreased tactile sensitivity. Healthcare providers should monitor patients for potential adverse effects during treatment.