On June 21, 2019, the U.S. Food and Drug Administration (FDA) announced the approval of Vyleesi™ (bremelanotide) as a novel therapy to treat generalized hypoactive sexual desire disorder (HSDD) in pre-menopausal women. HSDD is a disorder characterized by sexual dysfunction and distress that is not attributed to another medical problem and is estimated to affect 10% of women in the U.S. In clinical trials, Vyleesi™ was shown to significantly improve sexual desire scores and reduce distress scores compared to placebo. Vyleesi™ is the first drug approved to treat HSDD since the FDA issued a draft guidance in 2016 to assist companies developing drugs for HSDD treatment. Vyleesi™ will offer patients a treatment alternative to Addyi® (flibanserin), which was approved in 2015 as the first therapy to treat HSDD.
On June 25, 2019, the U.S. FDA issued warning letters to Cali Botanicals and Kratom NC for the illegal sale and marketing of unapproved and misbranded kratom products. Kratom, a plant species native to Southeast Asia, is being increasingly sought out due to its opioid-like properties that can cause mind-altering effects. The warnings were issued in response to unsubstantiated claims about kratom’s ability to treat opioid addiction, pain and depression, among others. The FDA stressed that selling unapproved kratom products with misleading claims about its efficacy is a violation of the Federal Food, Drug, and Cosmetic Act. The FDA reminded consumers that there are no FDA-approved uses for kratom and warned not to use any products containing kratom or its related compounds.
The new analysis, covering 60 million people across 14 different countries, found that the incidence of precancerous lesions and genital wart infections sharply declined in individuals that received HPV vaccination. HPV is the most common sexually transmitted infection (STI) in the U.S. and can cause health problems such as genital warts and cancer, if it does not resolve on its own. In the analysis, researchers saw a reduction in infections caused by the two most common cancer-inducing strains of HPV (HPV 16 and 18) for both girls aged 13-19 years and women aged 20-24 years. The study also found a 67% and 48% reduction in anogenital warts among girls and boys aged 15-19, respectively. Most notably, as the first study to measure precancerous lesions as a predictor of cancer, researchers found that precancerous cervical lesions declined by 51% among girls aged 15-19 years.
Novel Drug Approval: Vyleesi™ (bremelanotide) (polatuzumab vedotin-piiq)
Subcutaneous injection for the treatment of generalized hypoactive sexual desire disorder (HSDD) [6/21/2019 – AMAG PHARMS INC]
New Biosimilar: Zirebev™ (bevacizumab-bvzr) Reference Product: Avastin™ (bevacizumab)
Intravenous injection for the treatment of select cancers [6/27/2019 – PFIZER INC]
Indication: Nausea and vomiting of pregnancy
Dosage Form/Strength: 10MG-10MG Tablet
Average Wholesale Price (AWP): Generic = 10MG-10MG ($888) | Brand = 10MG-10MG ($988)