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Ovoca's female sexual disorder drug improves libido in phase 3 trial

Ovoca Bio PLC plans to file for Russian approval of its medicine Libicore after the drug improved the number of sexually satisfying events in women in a late-stage study.

The Dublin-based pharmaceutical company's stock was up by 20.44% to 8.13 pence as of 9:18 a.m. London time on the London Stock Exchange.

Ovoca's majority-owned Russian company IVIX LLC evaluated Libicore, which is administered through a nasal spray, against placebo in a phase 3 trial consisting of 189 premenopausal women with hypoactive sexual desire disorder, or HSDD, in the Russian Federation.

HSDD, also known as inhibited sexual desire, is a lack or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty.

After four weeks of treatment and two months of follow-up, a 2.52-milligram self-administered daily dose of Libicore, or BP-101, showed a statistically significant increase in the number of satisfying sexual events against placebo.

The medicine also showed statistically significant improvement over placebo and met the secondary goals of the trial. Libicore helped improve sexual functioning in women, measured by points in a questionnaire that evaluated sexual function in women.

The drug also showed a statistically significant mean reduction in sexually related personal distress in women, measured on the female sexual distress scale.

Ovoca said that Libicore was safe and well tolerated in the study.

The company added that it will seek Russian approval for Libicore during the second quarter of the year.

The Irish pharmaceutical company said it has planned meetings with the U.S. and German regulators based on which it expects to start clinical trials in the U.S. and European countries in the middle of 2020.