New drug for dyspareunia due to menopause approved by FDA
The FDA approved estradiol vaginal inserts (Imvexxy) for moderate-to-severe dyspareunia due to menopause. The estradiol vaginal insert is a softgel capsule that is administered intravaginally without an applicator once daily for 2 weeks, followed by 1 insert twice weekly. The estradiol vaginal insert is a product of TherapeuticsMD and dosages include 4 mcg and 10 mcg strength inserts in 8- and 18-count packs. The 4 mcg dose represents the lowest approved dose of vaginal estradiol available.
In a 12-week clinical trial of estradiol vaginal insert versus placebo, treatment with the insert led to relief of moderate-to-severe dyspareunia due to menopause as early as week 2 for both the 4 mcg and 10 mcg strength inserts. In addition, treatment was associated with statistically significant changes in vaginal cytology and pH.
Headache was the most frequent adverse reaction associated with estradiol vaginal insert treatment in clinical trials. Labeling for this product includes a boxed warning about the risk of endometrial cancer, cardiovascular disorders, breast cancer, and an increased risk of probable dementia in postmenopausal women age 65 and older.
FDA approved first preventive migraine drug
The FDA approved erenumab-aooe (Aimovig), a once-monthly subcutaneous injection, for the preventive treatment of migraine in adults. It is the first approved migraine preventive treatment from a new class of drugs, calcitonin gene-related peptide receptor (CGRP) antagonist, that works by binding to the CGRP receptor and antagonizing CGRP receptor function. CGRP is synthesized and released from sensory nerves in the central nervous system and is involved in migraine attacks.
Erenumab-aooe, a product of Amgen, is indicated for migraine prevention in adults and is self-administered using Amgen's SureClick autoinjector after the patient receives training on the drug and device by the provider. Erenumab-aooe was approved based on the results of three clinical trials that showed significant reductions in monthly migraine days and use of acute migraine medications compared with placebo. Positive effects of treatment were sustained for up to 15 months.
* The first study, comparing erenumab-aooe with placebo in 955 patients with episodic migraine, found that over 6 months, the erenumab-aooe-treated patients had 1 to 2 fewer monthly migraine days than those on placebo.
* The second study, which evaluated 577 patients with episodic migraine, found that over 3 months, erenumab-aooe-treated patients experienced on average 1 fewer migraine day per month than those on placebo.
* The third study, which examined 667 patients with a history of chronic migraine, showed that over 3 months, erenumab-aooe-treated patients experienced an average of 2.5 fewer monthly migraine days than those on placebo.
The most commonly reported adverse reactions in the clinical trials were injection site reactions and constipation.
Combination treatment approved for overactive bladder
The FDA approved a supplemental new drug application for use of mirabegron (Myrbetriq) in combination with solifenacin succinate (Vesicare) for the treatment of overactive bladder (OAB) accompanied by symptoms of urge urinary incontinence, urgency, and urinary frequency. Both drugs are products of Astellas Pharma.
The combination therapy can help patients with OAB who have symptoms not fully managed with their current treatment. The approval follows consideration of data from three large, global phase-III trials comparing combination therapy with monotherapy. The studies showed that the combination therapy was superior to monotherapy with solifenacin alone for relieving symptoms of incontinence and frequent urination.
The most common adverse reactions reported to be associated with mirabegron are hypertension, nasopharyngitis, urinary tract infection, constipation, diarrhea, dizziness, and headache. The most common adverse reactions associated with solifenacin are xerostomia, constipation, and blurred vision.