A pill to treat low sexual desire in women was rejected by U.S. regulators, a decision that has been appealed by the drugs maker in a bid to make it the first product for the disorder.
The U.S. Food and Drug Administration based its decision to turn down the medicine on what the agency called a modest effect, closely held Sprout Pharmaceuticals Inc. said today in a statement. Sprout, based in Raleigh, North Carolina, is seeking approval of the therapy, known as flibanserin, as an option for women whose low libido causes stress in their lives.
In clinical trials, Sprouts pill almost doubled the increase women saw in satisfying sexual experiences over a months time compared with patients who took a placebo, the company said. The agencys decision contrasts with its review of drugs to treat male sexual dysfunction, Cindy Whitehead, president and chief operating officer at Sprout, said in an interview. The agency on Dec. 6 issued its 24th approval of a treatment for male sexual dysfunction, an injection called Xiaflex to treat a condition that causes a curved penis.
I do believe that women deserve a solution to their most common form of sexual dysfunction, Whitehead said. Flibanserin has been in 11,000 patients at this point. Its pretty well defined.
The FDA accepted Sprouts appeal on Dec. 3 after turning down the drug about two months ago. Because Sprout isnt publicly traded, the company didnt make public when the pill was rejected.
Flibanserin, if approved, would treat a sexual disorder known as female hypoactive sexual desire disorder, which is low libido that causes stress, according to Sprout. The drug is indicated for use by women who havent yet gone through menopause.
I think this could be a blockbuster drug, Whitehead said.
Sprout expects to hear FDAs decision on its appeal in the first quarter of next year.
Treatments for female sexual dysfunction have lagged behind those for men in the 15 years since Pfizer Inc. (PFE)s Viagra was approved for erectile dysfunction. Treatment for men has since grown into a $4.4 billion market in 2012, according to data compiled by Bloomberg.
Pfizer gave up studying Viagra for women in 2004. BioSante Pharmaceuticals Inc.s testosterone gel for women failed to work in two large studies in 2011.
Follow this link:
Female Sexual Desire Drug Rejected by U.S. Regulators
- Testosterone gel - Drugs dot com - April 12th, 2021
- Testosterone cream and gel for supplementation treating hypogonadism - March 13th, 2021
- Testosterone Gel Information - September 9th, 2020
- Testosterone Creams for Low Testosterone Treatment and Andropause - August 10th, 2020
- What Causes Dark Circles Under Your Eyes? - May 16th, 2020
- Testosterone Replacement Beneficial for Modern Men? - February 11th, 2020
- Tefina nasal gel claims to boost number of orgasms a woman can have - June 18th, 2019
- LowTestosterone.com - Testosterone Gel - August 11th, 2016
- AndroGel testosterone gel - Drug information from MediLexicon - June 15th, 2016
- Side Effects of Testim (Testosterone Gel) Drug Center - RxList - May 5th, 2016
- DailyMed - TESTIM - testosterone gel - May 3rd, 2016
- Testosterone gel is no fountain of youth, study finds - CBS News - April 10th, 2016
- DailyMed - TESTOSTERONE- testosterone gel - February 8th, 2016
- Testosterone Gel & Testicular Shrinkage! - October 24th, 2015
- Testim (Testosterone Gel) Drug Information: Medication ... - October 24th, 2015
- Low Thyroid Level Symptoms | HagglundMD.com Thyroid Doctor - September 26th, 2015
- List Of Low-Carb Doctors - September 25th, 2015
- AndroGel (testosterone gel) - August 12th, 2015
- AndroGel® (Testosterone Gel) 1.62% - August 2nd, 2015
- Testim gel: Indications, Side Effects, Warnings - Drugs.com - July 3rd, 2015
- Testim (Testosterone Gel) Drug Information: Description ... - July 3rd, 2015
- DailyMed - TESTOSTERONE- testosterone gel, metered - July 3rd, 2015
- Testosterone Gel Treatment of Gynecomastia | eHow - April 6th, 2015
- Why Repros Therapeutics, Inc. Shares Are Soaring - April 2nd, 2015
- Low T Treatment | FORTESTA (testosterone) Gel CIII - March 17th, 2015
- Testosterone Gel - How RS Transaderm makes your test ... - March 12th, 2015
- MEDICATION GUIDE Testosterone (tes-TOS-te-rn) Gel, CIII - March 12th, 2015
- High testosterone ups heart disease risk in men - March 10th, 2015
- Men's heart disease risk linked to high testosterone and low estrogen - March 9th, 2015
- Higher heart disease risk for men due to high testosterone, low estrogen - March 9th, 2015
- Vital Health, Inc. Provides Tips On How To Combat Cystic Acne Through Dietary Changes and Natural Remedies - February 20th, 2015
- Men, women: Why cholesterol matters - January 30th, 2015
- Gilead rival AbbVie's new hepatitis C treatment wins EU approval - January 20th, 2015
- Testosterone Gel A Convenient, Natural Solution - December 30th, 2014
- Doctor's Testosterone Gel - Buy Doctors Testosterone Gel ... - December 28th, 2014
- DailyMed - ANDROGEL- testosterone gel - November 25th, 2014
- Endo Int'l Buys Rights To Natesto Testosterone Nasal Gel From Trimel BioPharma - November 25th, 2014
- Secaucus police officer charged with selling steroid gel on eBay: officials - November 18th, 2014
- What Are the Benefits of Testosterone Gel? | eHow - November 2nd, 2014
- AbbVie Sales Blow Past Expectations - October 31st, 2014
- Buy Cernos Gel, Buy Testosterone Gel from Certified Online ... - October 28th, 2014
- testosterone gel (Androgel): Drug Facts, Side Effects and ... - October 3rd, 2014
- Woman Says Dentists Testosterone Gel Rubbed Off On Her During Sexual Attack, Causing Her To Grow Unsightly Body Hair - September 30th, 2014
- Androxal superior to Androgel in Phase 3 trial - September 27th, 2014
- 'When I look at myself I am not impressed at all' - August 2nd, 2014
- Don't Make This Big Investing Mistake Once Interest Rates Start Rising - August 2nd, 2014
- Why Isn't This Swirling Low in the Atlantic a Tropical Storm? - August 2nd, 2014
- As Political Disenchantment Soars, Lines At The Polls Grow Shorter - July 26th, 2014
- Love Letters: We Don't Have Much To Talk About - July 26th, 2014
- Wonkblog: Britains economy is finally bigger than it was in 2008. What took so long? - July 26th, 2014
- Wounded veteran is standing tall, looking to the future - July 6th, 2014
- Testosterone Nasal Gel Claims To Help Women Reach Orgasm (And Has 'No Side Effects') - June 18th, 2014
- Book Extract: Set ambitious targets to win - June 2nd, 2014
- Double Blessing For Trimel Pharma... - May 31st, 2014
- Testosterone Gels - May 1st, 2014
- Andractim Testosterone Gel for Testosterone Replacement ... - April 30th, 2014
- AUXL Gives Bleak Outlook, IG Reverses Loss, ENDP Opens Wallet, BOTA Stops Work - April 30th, 2014
- How to Apply Testosterone Gel - 31 Day Testosterone Plan - Video - April 22nd, 2014
- Is Your Husband At Risk for a Testosterone Heart Attack? - April 16th, 2014
- Testosterone Cypionate | Best Testosterone Supplments - April 14th, 2014
- Low T Litigation - Video - April 2nd, 2014
- Perrigo sues FDA over failure to grant therapeutic equivalence rating for testosterone gel - March 24th, 2014
- Testosterone Monograph for Professionals - Drugs.com - March 7th, 2014
- Could the male hormone testosterone transform a woman's looks, life and libido? - March 6th, 2014
- Group wants heart attack warning on testosterone - Quincy Herald-Whig | Illinois & Missouri News, Sports - February 25th, 2014
- Startling Effects of Testosterone Therapy - February 8th, 2014
- Questions & Answers 195 - Video - February 5th, 2014
- Testosterone Tx Ups Heart Attack Risk at Any Age - January 31st, 2014
- Testosterone Treatments Linked to Heart Attacks - January 30th, 2014
- Testosterone gel: Indications, Side Effects, Warnings ... - January 23rd, 2014
- Testosterone Gel Vs. Patch | eHow - eHow | How to Videos ... - December 24th, 2013
- AndroGel (Testosterone Gel for Topical Use) Drug Information ... - December 24th, 2013
- Best Natural Testosterone Booster (Get FREE Bottle) - Video - December 23rd, 2013
- Manufacturers of "female Viagra" appeal FDA denial - December 12th, 2013
- Side Effects of AndroGel (Testosterone Gel for Topical Use ... - December 10th, 2013
- Testosterone Gel Treatment | eHow - eHow | How to Videos ... - December 6th, 2013
- Testosterone Gels | Do They Work? - December 5th, 2013
- Testosterone skin gel: Information from Answers.com - November 28th, 2013
- AndroGel testosterone gel New FDA Drug Approval | CenterWatch - November 23rd, 2013
- What is Testosterone Gel? | Consumer Health PanelConsumer ... - November 18th, 2013
Word Count: 386