The pipeline runneth over
HPV vaccine is next in a long line of new drugs that will change women’s health care more than anything since the Pap test.
Transdermal estradiol gel (Bio-E-Gel; BioSante Pharmaceuticals, Lincolnshire, Ill) is intended to treat vasomotor symptoms. Transdermal estradiol has demonstrated efficacy for treatment for vasomotor symptoms when applied in various formulations, including patches and gels.
2 sexual dysfunction drugs
Alprostadil (Alista; Vivus, Mountain View, Calif) is a synthetic PGE1 formulation intended to be applied to the genital tissues to increase genital blood flow and sensitivity and sexual arousal.
Testosterone gel (Tostrelle; Cellegy Pharmaceuticals, Brisbane, Calif) is intended to treat hypoactive sexual desire disorder in menopausal women by increasing androgen levels toward the normal premenopausal range.
Fibrocystic breast pain
Molecular iodine (IoGen; Symbollon, Framingham, Mass) is intended for treatment of severe periodic breast pain associated with fibrocystic breast disease. Molecular iodine treatment increases the concentration of iodolactones that may be antiproliferative and apoptotic in breast tissue.
Contraceptives fight STDs
1% C31G vaginal gel (Savvy; Cellegy Pharmaceuticals, Brisbane, Calif, and Biosyn Philadelphia, Pa) is a vaginal spermicide and microbicide intended to reduce the risk of both pregnancy and transmission of sexually transmitted diseases, including HIV disease. C31G contains 2 surface-active agents, cetyl betaine and myristamine oxide, in an equimolar mixture in a hydroxyethyl cellulose gel.
Ushercell (Polydex Pharmaceuticals, Toronto, Ontario, Canada), a high-molecular-weight cellulose sulfate compound, is a topical contraceptive and microbicide. Ushercell is intended for intravaginal use to protect against transmission of HIV, gonorrhea, chlamydia, and herpes simplex virus 1 and 2.
Obstetrics pipeline: Not even a trickle
Once these new medications are approved for use by the FDA, a complex process will begin as clinicians and patients work together to try to understand the best approaches to balance benefits and adverse effects of these medicines in practice.
An interesting side note is that none of these new medications has any obstetrical indication; all are focused on gynecological and women’s health clinical problems. The paucity of pharmaceutical innovation focused on obstetrical diseases continues to plague our field.
What is your top concern?
We would like to know what specific clinical problems you face in your daily practice. What problems deserve additional focus and resources from the pharmaceutical discovery industry?