Femasys Inc. checked off a box on the way to launch of its Fembloc non-surgical birth control method with U.S. FDA clearance of Femchec. An enhanced version of the Femvue product used to diagnose fallopian tube abnormalities, Femchec enables confirmation of successful blockage of the fallopian tubes to prevent pregnancy without use of radiation.
Swiss scientists developed hydrogel implants that could help prevent and treat endometriosis by blocking the fallopian tubes and stopping the passage of endometrial cells. The implants, though in their early stage of development, bode well for the millions of women suffering from the chronic condition.
Researchers from Oregon Health and Science University (OHSU) are seeking patent protection for a transcervical delivery device that may provide clinicians with a simple, inexpensive office-based procedure for the assessment of tubal patency or delivery of a permanent contraceptive agent to the fallopian tube.
If timing is everything, Femasys Inc.’s Fembloc has everything on its side. While the company’s dual tracks addressing infertility and providing permanent contraception may appear at odds, they both serve to put greater control of reproductive decisions and treatment in the hands of women. A permanent contraceptive, Fembloc offers an alternative to surgical tubal ligation by encouraging scar tissue growth in the fallopian tubes in an office-based procedure.
Nearly four years after differences between U.S. and Russian clinical results derailed an NDA for its pregnancy prevention candidate, Phexxi, San Diego-based Evofem Biosciences Inc. has prevailed, winning FDA approval today for the vaginal pH regulator.
Researchers are hopeful that within three to five years the first once-a-month oral contraceptive could reach human testing. They achieved an early step on that path with the publication of research testing the long-lasting drug delivery device from Watertown, Mass.-based startup Lyndra Therapeutics Inc. in the Dec. 4, 2019, issue of Science Translational Medicine.
Researchers are hopeful that within three to five years the first once-a-month oral contraceptive could reach human testing. They achieved an early step on that path with the publication of research testing the long-lasting drug delivery device from Watertown, Mass.-based startup Lyndra Therapeutics Inc. in the Dec. 4 issue of Science Translational Medicine.
Agile Therapeutics Inc. didn't feel much love Wednesday from FDA reviewers who questioned the efficacy of its Twirla birth control patch, but it got a warm embrace from the Bone, Reproductive and Urologic Drugs Advisory Committee, which voted 14-1, with one abstention, that Twirla's benefits outweigh its risks.
After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success.
