Study With Investigational Drug Showed Symptom Relief in Postmenopausal Women
/ADVANCE/ LOS ANGELES, March 22 /PRNewswire/ -- A randomized, double-blind, Phase III, placebo-controlled clinical trial in postmenopausal women presented today at the Society for Gynecologic Investigation's 49th Annual Scientific Meeting, showed patients using Estrasorb (estradiol topical emulsion) experienced an eighty-five percent reduction in the total number of hot flashes during the course of the trial. The study also found that nearly half the patients reported complete cessation of hot flashes during a 7-day period by week 10 of treatment, while fewer than 10% of patients in the placebo group noticed a similar improvement in symptoms.
Estrasorb is a new drug that is currently being reviewed by the Food and Drug Administration (FDA) for the treatment of moderate to severe vasomotor symptoms (hot flashes, night sweats) in postmenopausal women. It is a lotion-like formulation used once a day. If approved by the FDA, it would be the first estrogen replacement therapy (ERT) in this formulation.
Studies have shown that Estrasorb delivers a sustained release of estradiol through the skin. In the study reported today, steady state blood levels of estrogen were reached by the eighth day of daily administration of Estrasorb. Symptom relief was consistent throughout the patient population, according to study results.
"Estrasorb has the potential to provide a continuous, controlled release of estrogen into the bloodstream without the local irritation of transdermal patches or the vagaries of delivery seen with some oral forms of estrogen replacement therapy," said James Simon, MD, Clinical Professor of Obstetrics and Gynecology at George Washington University School of Medicine in Washington DC.
Approximately 38% of postmenopausal women in the United States currently receive ERT for symptoms including hot flashes. Various studies show that the side effects and complications of this class of medication contribute to a low rate of compliance. Fewer than 28% of women actually remain on ERT after only two years of therapy. If approved by the FDA, Estrasorb's unique delivery system would provide postmenopausal women an alternative to currently available ERT therapies.
Estrasorb uses Novavax's micellar nanoparticle technology for the systemic delivery of ethanol-soluble drugs. According to Dr. Simon, "Estrasorb has a silky, moisturizing quality similar to other lotions women regularly use which may enhance its appeal. More than 90% of the women in the trial were fully compliant with treatment."
Menopause represents the permanent end to ovulation and menstruation. According to the US Census Bureau, there were more than 41 million women 50 years or older living in the United States in 2000. By the time they are 50, most women experience menopausal symptoms or are postmenopausal.
During menopause, estrogen levels decrease, putting women at risk for a host of symptoms. The National Institute on Aging reports that hot flashes are the most common symptom of menopause, affecting more than 60% of menopausal women in the United States. Hot flashes are characterized by sudden and intense sensations of heat, often associated with an increased heart rate, profuse sweating and red, blotchy skin. Severe hot flashes can interrupt sleep, cause insomnia and disrupt normal daily activities. Maintaining adequate estrogen levels can relieve hot flashes.
Trial Results
The study, which enrolled 200 women who were naturally or surgically menopausal, consisted of a 3-week screening period, a 1-week placebo period, and a 12-week randomized treatment period. A 3-gram dose of Estrasorb with 7.5 mg estradiol (100 patients) or placebo lotion (100 patients) was applied daily to each thigh and calf. Hot flash data was collected and recorded in a patient diary.
In the study, adverse effects with Estrasorb were similar to placebo and consistent with estrogens as a class. The most common adverse events included endometrial disorder, breast pain, vaginal hemorrhage and vaginal moniliasis. Patients in the Estrasorb treatment group had transient skin irritation defined as mild-to-moderate itching (5%) or redness (1%).
Novavax, Inc., is a specialty biopharmaceutical company engaged in the research, development and commercialization of proprietary products focused on women's health and infectious diseases. Novavax has several product candidates in pre-clinical and human clinical trials including Estrasorb, Androsorb(TM), a transdermal testosterone lotion in Phase I/II clinical trials and Andro-Ject(TM), a long-acting subcutaneous injectable formulation of testosterone that is in pre-clinical development. Novavax conducts research and development on preventative and therapeutic vaccines for a variety of infectious diseases. Novavax is a committed partner in women's health for today's woman and a proud sponsor of the national tour of Menopause The Musical, a grassroots celebration of women who are on the brink of, in the middle of, or have survived The Change. |
