First Prescription Prasterone Approved
November 17, 2016 – The US FDA announced that it approved Intrarosa™ (prasterone) vaginal inserts to treat vulvovaginal atrophy (VVA), manufactured by EndoCeutics. VVA is a condition that makes having sex painful and difficult for many women after menopause due to alkalinity, dryness, irritation and thinning of the female lower reproductive tract. Also widely known as DHEA (dehydroepiandrosterone), prasterone is a natural steroid hormone produced mainly by the adrenal glands and then converted into estrogens and androgens. Biological prasterone production gradually decreases, beginning at about 30 years of age, resulting in declining levels of the sex hormones. At menopause, estrogen levels drop further. Usually marketed as DHEA, oral forms of prasterone are sold over the counter as nutritional supplements, but no evidence supports their effectiveness for any medical condition. Intrarose is the first prescription prasterone to be FDA approved. It will be available as 6.5mg vaginal inserts that are used once a day.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.