Abnormal Uterine Bleeding (AUB)

Abnormal Uterine Bleed (AUB) is a major unmet health issue affecting more than three million women in the US. For women with chronic AUB, blood loss can be great enough to cause anemia, fatigue, and syncope (fainting), in addition to adversely affecting their quality of life.  Women of any age can experience AUB, which accounts for one-third of all gynecologic visits and more than 25 percent of all gynecologic surgeries.

Medical treatment of AUB with available drugs is often unsuccessful and leads to unacceptable side effects. For women that have finished childbearing, hysterectomy may provide a definitive solution to the problem.  Hysterectomy is major surgery in which the entire uterus is removed. The procedure requires a hospital stay.   Recovery can take up to six weeks and patients may feel tired for longer. Normal activities can be resumed in four to eight weeks post surgery and sexual activity in six to eight weeks.  The risks of having a hysterectomy are similar to those with major abdominal operations and include blood clots, severe infection, hemorrhages (which may require a blood transfusion), bowel obstruction, and injury to the urinary tract or other internal organs. Possible complications following surgery include fever, urinary tract infection, constipation, and pain or discomfort during sex.

While hysterectomy is often performed to address abnormal bleeding, women are beginning to elect less-invasive procedures to remove the endometrium, the lining of the uterus, via a procedure called endometrial ablation.

Endometrial ablation is a minor procedure than can be performed in less than 45 minutes and does not require a hospital stay. No cuts are made and, depending on the procedure used, patients generally recover fully within a few hours or days.

Various methods are employed to ablate the endometrium using heat, extreme cold, energy, or laser.  Following the procedure, periods will be a lot lighter or may stop altogether.  In order to achieve  optimal patient outcomes in terms of stopping periods completely or significantly reducing their volume, the full thickness of the endometrium must be removed to prevent regrowth and recurrent bleeding.  Available FDA-approved products for endometrial thinning have drawbacks and so are not routinely used. The only approved GnRH agonist for the thinning indication must be injected for one to two months prior to the procedure, and is not well tolerated by some women.

Meditrina’s most advanced product candidate, Femathina™ (MPI-674), is an aromatase inhibitor (AI) under investigation for its endometrial thinning effect in premenopausal women prior to undergoing endometrial ablation or resection to treat AUB.  MPI-674’s advantages over currently available drugs may include once daily oral dosing, shorter treatment duration prior to the procedure, an established safety and tolerability profile, and cost effectiveness.