U.S. FDA Includes Cytisinicline for Vaping Addiction in National Priority Voucher Program, Shortens Review to 1–2 Months

Key Points：

• FDA awards first-ever National Priority Vouchers — Nine drugs selected for accelerated review, including Cytisinicline for nicotine vaping addiction.

• Review timeline significantly reduced — From the standard 10–12 months to just 1–2 months, boosting regulatory efficiency for innovative therapies.

• Cytisinicline targets vaping addiction — Developed by Achieve Life Sciences, the drug has already received Breakthrough Therapy Designation.

• Potential first treatment for e-cigarette dependence — Could fill a critical gap in therapies addressing nicotine vaping addiction.

• Public health priorities emphasized — The CNPV program focuses on addiction treatment, chronic disease prevention, and strengthening domestic pharmaceutical manufacturing.

October 20, 2025 — 2Firsts, Washington D.C. — The U.S. Food and Drug Administration (FDA) has announced nine drugs selected under its new Commissioner’s National Priority Voucher (CNPV) pilot program, aimed at expediting the review of medicines and biologics that address critical national public health challenges.

According to the FDA, selected products must demonstrate strong potential to meet large unmet medical needs, reduce healthcare system burden, address public health crises, strengthen domestic manufacturing, or improve drug affordability through Most Favored Nation pricing mechanisms.

Among the inaugural recipients is Cytisinicline, a plant-derived compound being developed as a treatment for nicotine vaping addiction, a growing health concern in the United States.

Accelerated Review and Regulatory Focus

The CNPV program shortens the standard drug review timeline from 10–12 months to 1–2 months.

Selected sponsors will receive more frequent communication and regulatory guidance throughout the review process.

FDA scientists, however, retain the authority to extend the review period if an application is incomplete, manufacturing violations are found, or additional evaluation is deemed necessary.

FDA Commissioner Dr. Marty Makary said the initiative reflects the agency’s goal to “modernize the review process and accelerate access to therapies that have a meaningful impact on public health.”

Cytisinicline: A Potential First for Vaping Addiction Treatment

Cytisinicline, developed by Achieve Life Sciences, is a plant-based alkaloid that binds to nicotinic acetylcholine receptors in the brain, helping reduce withdrawal symptoms and the rewarding effects of nicotine.

In July 2025, the FDA granted Cytisinicline Breakthrough Therapy Designation for treating nicotine vaping addiction.

If ultimately approved, it would become the first medication specifically indicated for e-cigarette dependence, addressing a major unmet need in addiction treatment.

Other Drugs Selected

Pergoveris – Infertility treatment

Teplizumab – Type 1 diabetes

DB-OTO – Genetic deafness

Cenegermin-bkbj – Blindness

RMC-6236 – Pancreatic cancer

Bitopertin – Porphyria

Ketamine – Domestic manufacturing of general anesthesia drugs

Augmentin XR – Domestic production of a common antibiotic

The FDA said it plans to announce another group of National Priority Voucher recipients in the coming months.

Cover image: KFF Health News