Amneal Receives U.S. FDA Approval of New Drug Application for Pyridostigmine Bromide Extended-Release Tablets

Rhea-AI Summary

Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg. This once-daily product is designed for pretreatment against soman nerve agent poisoning in adults, specifically for the U.S. Armed Services and allies. Developed using Amneal's GRANDE® drug delivery technology, it offers potential for improved compliance and steady 24-hour release, replacing the current thrice-daily dosing regimen.

The project was partially funded by the U.S. government under Agreement W911QY-21-9-0018. This marks Amneal's second NDA approval this year, following CREXONT for Parkinson's disease. The most common serious adverse reactions reported were breathing difficulties, dizziness, and loss of consciousness.

Positive

• FDA approval of New Drug Application for Pyridostigmine Bromide Extended-Release Tablets
• Once-daily dosing potentially improving compliance for U.S. Armed Services
• Utilization of proprietary GRANDE® drug delivery technology
• Second NDA approval for Amneal this year, demonstrating R&D success

Negative

• Serious adverse reactions reported including breathing difficulties and loss of consciousness
• market potential as product is specifically for U.S. Armed Services and allies

Insights

Pharmaceutical Industry Analyst

The FDA approval of Amneal's Pyridostigmine Bromide Extended-Release (PB ER) tablets represents a significant advancement in nerve agent pretreatment for the U.S. military. This once-daily formulation, developed using Amneal's proprietary GRANDE® technology, offers several key advantages:

• Improved compliance due to reduced dosing frequency (once daily vs. three times daily)
• Steady 24-hour drug release, potentially enhancing effectiveness
• Simplified administration for service members in the field

From an investor perspective, this approval is noteworthy for several reasons:

• It demonstrates Amneal's R&D capabilities and innovative drug delivery technology
• Secures a potentially lucrative government contract
• Expands Amneal's product portfolio in a niche, high-value market
• Showcases the company's ability to work with government agencies on critical projects

While the immediate financial impact may be due to the specialized nature of the product, this approval could open doors for future government collaborations and enhance Amneal's reputation in the pharmaceutical industry. Investors should view this as a positive indicator of the company's diversification strategy and technological capabilities.

Pyridostigmine Bromide Extended Release is a once-daily soman nerve agent pretreatment pyridostigmine product for the U.S. Armed Services and U.S. allies developed utilizing Amneal’s GRANDE^® drug delivery technology

Developed with the support of Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company based in the U.S., today announced that it has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg.

PB ER 105 mg tablets are a once-daily, orally administered product indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults 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 PB product that is administered every eight hours and avoiding the need for service members to self-administer three times a day.

This product was not previously disclosed and was developed with Amneal’s GRANDE^® drug delivery technology, which is an advanced gastric retention system that allows for sustained delivery drug release. This project was funded in part by the U.S. government under Agreement W911QY-21-9-0018.

“Amneal is proud to receive our second NDA approval this year, after the recent approval of CREXONT for Parkinson’s disease. 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.

The most frequently reported serious adverse reactions were breathing difficulties, dizziness, and loss of consciousness. Other reported adverse reactions observed included dysmenorrhea, nosebleeds, reduced vision in one eye, and decreased tactile sensitivity.

Disclaimer: The views and opinions of authors expressed herein do not necessarily state or reflect those of the U.S. government and shall not be used for advertising or product endorsement purposes.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

Disclaimer
The views expressed herein are those of Amneal and may not reflect the official policy or position of the Department of Defense (DoD) or the U.S. Government. Reference herein to any specific commercial products, process or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising or product endorsement purposes.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241021221510/en/

Investor Contact

Anthony DiMeo

VP, Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is the purpose of Amneal's newly approved Pyridostigmine Bromide Extended-Release Tablets (AMRX)?

Amneal's Pyridostigmine Bromide Extended-Release Tablets are indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults, developed specifically for the U.S. Armed Services and allies.

How does Amneal's new Pyridostigmine Bromide ER (AMRX) differ from the current product?

Amneal's new Pyridostigmine Bromide ER is a once-daily formulation, offering potential for improved compliance and steady 24-hour release, compared to the current product that requires administration every eight hours.

What technology did Amneal (AMRX) use to develop the Pyridostigmine Bromide Extended-Release Tablets?

Amneal used its proprietary GRANDE® drug delivery technology, an advanced gastric retention system that allows for sustained drug release, to develop the Pyridostigmine Bromide Extended-Release Tablets.

What are the main adverse reactions reported for Amneal's Pyridostigmine Bromide ER (AMRX)?

The most frequently reported serious adverse reactions for Amneal's Pyridostigmine Bromide ER were breathing difficulties, dizziness, and loss of consciousness. Other reported reactions included dysmenorrhea, nosebleeds, reduced vision in one eye, and decreased tactile sensitivity.