FDA Finalizes guidance for premarket tobacco product applications to check oversight of tobacco products and health issue

Electronic nicotine delivery systems (ENDS) are new artificial tobacco products which use artificial inhalers as a flavoring agent instead of burning tobacco leaves, such as e-cigarettes or vapes. Recently, U.S. Food and Drug Administration finalized the guidance for manufacturers of electronic nicotine delivery systems (ENDS) in a bid to keep a check on the health issues related to ENDS and to prevent the oversight of these tobacco products.1 The main objective of the guidance was to protect children from the harmful effects of tobacco products by creating an awareness about the risk and benefit of using the tobacco containing products manufactured via premarket tobacco product applications (PMTA). Moreover, this guidance further explains to the manufacturers about manufacturing conditions, packaging materials accidental exposure to e-liquids, such as child-resistant, exposure-limiting packaging or nicotine exposure warnings on labels. The FDA assures public via this guidance that the FDA will continue to take all necessary actions to protect children as part of their Youth Tobacco Prevention Plan.

FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

On June 21, 2019, U.S. Food and Drug Administration has approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is a sexual disorder characterized with low sexual desires in female. The condition is not due to any existing medical condition or any other psychiatric condition with partner. Acquired HSDD can occur in a patient who does not have any prior history of sexual disorder. The drug Vyleesi generally acts on melanocortin receptors, however, the mechanism of action for treating HSDD is still unknown. The drug should not be used for long periods of time and should be stopped within 8 weeks if there is no sign of improvement in sexual desire and associated distress. The effectiveness of the drug was clinically proved in two 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women. The end point of the study showed that 25% of the female patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo.2 The approval of the drug is a great achievement since from many years FDA is committed to continuing to work with companies to develop safe and effective treatments for female sexual dysfunction.

FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older.

On June 21, 2019, U.S. Food and Drug Administration today approved the expansion for Symdeko (combination of tezacaftor/ivacaftor), a drug used for the treatment of cystic fibrosis for treatment of pediatric patient of age 6 years and older with cystic fibrosis of certain genetic mutation.

Cystic fibrosis is a serious genetic disorder that results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems along with infections and diabetes. Earlier the drug was approved to be used in patients aged 12 and older with cystic fibrosis and genetic mutation. Expansion in indication of Symdeko provides an important treatment option for younger patients, and also provides more context on the safety and dosing specific to this population. The safety of Symdeko in patients age 6 to less than 12 years was supported by data from a study that included a 24-week, open-label treatment period with 70 cystic fibrosis patients ages 6 to less than 12, and had similar observations of safety to clinical trials in ages 12 and older. This approval was granted to Vertex Pharmaceuticals Incorporated. 3


1 https://www.fda.gov/news-events/press-announcements/fda-finalizes-guidance-premarket-tobacco-product-applications-electronic-nicotine-delivery-systems

2 https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hypoactive-sexual-desire-disorder-premenopausal-women

3 https://www.fda.gov/news-events/press-announcements/fda-expands-approval-treatment-cystic-fibrosis-include-patients-ages-6-and-older

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.