Exeltis Submits IPO Prospectus Following FDA Approval of Slynd, the First Progestin-Only Oral Contraceptive

VCBeat (WeChat ID: vcbeat) has learned from foreign media that Exeltis, a women’s health management company, recently announced that its new drug, Slynd, has received FDA approval for its New Drug Application (NDA). This medication is a novel oral contraceptive pill designed to prevent pregnancy in women within a specified timeframe.

Exeltis is a subsidiary of the global pharmaceutical group Insud Pharma. Exeltis primarily focuses on women’s medical needs in areas such as fertility, reproductive health, contraception, pregnancy, childbirth, and menopause, actively developing and manufacturing related pharmaceuticals and medical devices to improve the health outcomes of women worldwide. The company operates in more than 40 countries across the globe and employs over 4,000 professionals, dedicated to providing lifelong care for women. In recent years, however, Exeltis has expanded its business into fields including central nervous system disorders, ophthalmology, and endocrinology.

Slynd is a novel estrogen-free oral contraceptive containing 4 mg of drospirenone, a progestin-only pill (POP). The regimen consists of 24 active tablets and 4 inert tablets. Women should take the first active tablet on the first day of menstruation and continue taking one active tablet daily for 24 days, followed by one inert tablet daily for 4 days. If a dose is delayed or missed within 24 hours, Slynd maintains its contraceptive efficacy and ensures contraceptive safety.

Generally, the use of contraceptive pills containing drospirenone may increase the risk of thromboembolic events in women. Slynd is a synthetic form of progestin with pharmacological properties similar to those of the natural hormone progesterone. In clinical trials, no thromboembolic events were reported among women taking Slynd, and it does not cause many of the side effects associated with estrogen-containing contraceptives, such as dysmenorrhea, decreased libido, breast tenderness, uterine bleeding, and menstrual irregularities.

Salustiano Perez, President of Exeltis, stated that Slynd is the optimal choice for women who desire oral contraception while seeking to avoid the side effects associated with estrogen-containing contraceptives. Furthermore, Slynd represents an ideal contraceptive option for breastfeeding mothers.

Dr. Enrico Colli, Chief Scientific Officer at Exeltis, added, “We have confirmed the efficacy and safety of this contraceptive in high-risk populations, including smokers, older women, and individuals with a body mass index (BMI) greater than 30.”

It is worth noting that Slynd is contraindicated in patients with renal or hepatic impairment, such as those with renal insufficiency, adrenal insufficiency, or hepatic tumors. Furthermore, this medication is contraindicated in women with a history of progestin-sensitive cancers or undiagnosed abnormal uterine bleeding.

It is reported that Slynd will be commercially launched in the third quarter of 2019.

(Compiled by Wang Chan)