The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Slinda (drospirenone; Exeltis), an oral contraceptive for pregnancy prevention.
Slinda contains the synthetic progestin drospirenone in a 4mg dosage strength that is given in a 24/4 dose regimen. Drospirenone is a spironolactone analogue with antimineralocorticoid and antiandrogenic activity.
The NDA submission includes data from more than 3000 patients, for over 20,000 cycles; results showed that the progestin-only pill was comparable in efficacy to combined hormonal contraceptives. “No cases of thromboembolic events were reported in the entire clinical program,” said Enrico Colli, MD, Chief Scientific Officer. “The safety profile was demonstrated for all women, even higher-risk population segments, such as smokers, over-35s and obese patients.” According to clinical trial data, in cases where a Slinda pill was missed, there was no impact on efficacy during the following 24 hours.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for a decision on the NDA for May 27 2019.
For more information visit exeltisusa.com.