Oral Contraceptive OTC Proposal Moves Closer With Start Of Actual Use Study

HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.

Birth control dispenser

Recruiting has started for a 900-subject study that could be a key to submitting a new drug application to US FDA for making a daily oral contraceptive available OTC.

HRA Pharma SA started recruiting in April for an actual use trial, using progestin-only oral contraceptives with norgestrel 0.075...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Rx-to-OTC Switch

More from Health

Lupin Goes For Growth With Indian Consumer Health Spin-Off

 
• By 

With annual sales approaching $20m, LupinLife Consumer Healthcare has ambitious growth plans for the Indian OTC market.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

US Tariff Overhang Weighs on Chinese API Exports

 

Chinese API exports to US fell 24% year-on-year to $255m in May, when US and China called a truce in a previously escalating trade war.