Drugs

FDA Aims to Accelerate Nicotine Replacement Therapy Drugs

FDA commissioner Scott Gottlieb says the agency is prioritizing its efforts to help product developers bring novel nicotine replacement therapy (NRT) drugs to market. “We know that about 70% of adult smokers in the U.S. want to quit,” he says in an online post. “In fact, nearly half try to quit each year. But few succeed. Use of FDA-approved NRT products is generally considered to double the likelihood of a successful quit attempt (with variations between products).”

Most of existing products (gum, patches and lozenges) have been approved for more than 20 years, Gottlieb notes, adding that novel forms of nicotine delivery being developed with different characteristics or routes of delivery offer great promise. “We want to explore what new steps we can take using our regulatory policies to enable opportunities for innovation, while making sure these products are demonstrated to be safe and effective for their intended use,” he says.

Gottlieb says the agency’s Nicotine Steering Committee has been evaluating new, evidence-based opportunities to advance therapeutic nicotine products for combustible tobacco product cessation. “We have been examining the types of safety and efficacy studies that we suggest be conducted and the way that these products are used and labeled,” he says. “This work to re-evaluate and modernize our framework aims to provide clarity for companies seeking to avail themselves of the pathway to market safe and effective smoking cessation products.”

To further help developers, a draft guidance have been released — “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products,” which focuses on data recommended to evaluate potential toxicities associated with orally inhaled nicotine-containing drug products. A second draft guidance is expcted this fall that will help lay out a “framework for new potential clinically relevant outcomes for smoking cessation products, such as reducing the chance of a smoker going back to using cigarettes long term and showing a positive impact on certain measures of cardiovascular health,” Gottlieb says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome