FDA approves Prasterone (DHEA) for postmenopausal women experiencing dyspareunia.

Image courtesy: Prasterone.org

Clinical Pearls: 

·         Intrarosa Approval History

1.      FDA approved: Yes (First approved November 17th, 2016)

2.      Brand name: Intrarosa

3.      Generic name: prasterone

4.      Company: Endoceutics Inc.

5.      Treatment for: Dyspareunia

·         Local application of DHEA rapidly and effectively corrects the signs of vulvo-vaginal atrophy, relieving mild to moderate dyspareunia.

·         It has also shown marked improvement in all aspects of sexual function in post-menopausal women namely desire, arousal, orgasm, and pleasure.

·         It is devoid of any systemic increase in hormone level, thus avoiding potential systemic risks.

·         Prasterone (Intrarosa, Endoceutics Inc) is marketed as 0.50% (6.5 mg) Vaginal Ovules. 

The US Food and Drug Administration gave approval for use of prasterone (Intrarosa, Endoceutics Inc) to treat postmenopausal women complaining of moderate to severe pain during sexual intercourse (dyspareunia).[1]

Declining estrogen levels lead to Vulvovaginal atrophy (VVA) which has significant effect on women’s sexual health and quality of life (QOL). It is estimated that it affects 20% to 45% of midlife and older women, but only minority seek help for the symptoms. Nearly 93% of the women do not receive any treatment for the fear of estrogen related side effects. [2]

"Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women," said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER). "Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA."

Prasterone marketed as Intrarosa is manufactured by Quebec-based Endoceutics Inc. EndoCeutics is a private bio-pharma company operating in the field of women’s health and hormone-sensitive cancer prevention and treatment.[3]

 After the cessation of estrogen and progesterone by the postmenopausal ovaries, DHEA is the only exclusive source of these hormones made inside the vaginal cell layers physiologically by a process called as intracrinology. Intrarosa which comes as 0.50% DHEA (6.5 mg) daily vaginal insert does not have any systemic increase in circulating estrogens or androgens.

Per FDA, the efficacy of Intrarosa was demonstrated in a 12 week, prospective, randomized, double-blind, and placebo-controlled phase III clinical trial. The intent-to-treat population included 157 and 325 women in the placebo and DHEA-treated groups, respectively. Improvement was seen for all the four primary objectives namely percentage of parabasal cells, percentage or superficial cells, vaginal pH, and percentage of parabasal cells, percentage or superficial cells, vaginal pH, and moderate to severe pain at sexual activity (dyspareunia).[4] At clinical examination epithelial integrity, epithelial surface thickness, color and vaginal secretion showed marked improvement (86% to 121%) as compared to placebo effect (P < 0.0001).

No increase in systemic steroids levels was observed. The only side effects reported by 6% of women was an increase in vaginal secretions due to melting of the vehicle.

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[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm529641.htm

[2] http://www.endoceutics.com/therapeutic-areas/vulvovaginal-atrophy-vva/

[3] http://www.pr.com/press-release/652714

[4] http://journals.lww.com/menopausejournal/Citation/2016/03000/Efficacy_of_intravaginal_dehydroepiandrosterone.6.aspx