Pharmaceutical multinational Exeltis has received acceptance from the U.S. Food and Drug Administration (FDA) of the filing of Slinda (4 mg Drospirenone-only pill), a novel oral contraceptive developed by the company.
Slinda is an investigational estrogen-free oral contraceptive, with a 24/4 dose regimen that is believed to have a favorable safety and efficacy profile.
“Once available in the market, it could give an improved bleeding profile and greater flexibility, maintaining contraception efficacy for up to 24 hours in the event of a delayed or missed pill dosage,” said Yann Brun, managing director at Exeltis.
Drospirenone is a synthetic progestin with a pharmacological profile similar to natural-produced progesterone. As an estrogen-free contraceptive option, Slinda is expected to reduce the cardiovascular risks associated with combined hormonal contraceptives (CHCs) and to offer the advantages of drospirenone in terms of safety and tolerability, according to Exeltis.
The submission of Slinda is based on a development program involving more than 3,000 patients, generating over 20,000 cycles. The study showed that Drospirenone 4 mg-only pill has a clinical efficacy historically comparable to CHCs.
“No cases of thromboembolic events were reported in the entire clinical program,” said Enrico Colli, M.D., chief scientific officer, “The safety profile was demonstrated for all women, even higher-risk population segments, such as smokers, over-35s and obese patients.”
(Source: Exeltis via PR Newswire)