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Phase 3 trial of extended-release gabapentin reduced hot flashes

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ORLANDO, Fla. – Currently, the only FDA-approved treatment for hot flashes is hormone therapy. However, in an interview with Endocrine Today, JoAnn V. Pinkerton, MD, said an investigational formulation of extended-release gabapentin may improve this common symptom among menopausal women.

“The bottom line for me as a practitioner is that I need to have choices for my patients. For example, not all women can or choose to take hormone therapy (HT). They may have had breast cancer or have a strong family history of breast cancer, medical contraindicatin to HT or just don’t want to take HT,” Pinkerton told Endocrine Today. “We have no other FDA-approved options for bothersome hot flashes. Patients can try over-the-counter medications, deep breathing, acupuncture therapy or yoga, but what we want as practitioners is to be able to tell a patient that we have an FDA-approved treatment which we know is effective, safe and has been tested in highly symptomatic women.”

A New Drug Approval (NDA) was submitted to the FDA for extended release gabapentin (Serada, Depomed) for the treatment of menopausal hot flashes in July 2012.

Pinkerton, the medical director of the Midlife Health Center and professor obstetrics and gynecology at the University of Virginia, served as a primary investigator for the multicenter phase 3 clinical trial, BREEZE 3, consisting of 600 menopausal women (mean age 54 years).

The prospective, multicenter, randomized, double blind, placebo controlled study results were presented at the North American Menopause Society 23rd Annual Meeting.

Pinkerton and colleagues assessed the efficacy and safety of the non-hormone, non-antidepressant, gabapentin extended release (G-ER) 1,800 mg daily in a divided dose (600 mg in the morning and 1,200 mg in the evening) compared with placebo.

They examined its effect on reducing the average daily frequency and severity score of moderate-to-severe hot flashes in postmenopausal women at week 4 and week 12 of treatment, compared with baseline measurements.

Of the 600 patients, 397 completed 24 weeks of treatment (n=206; 68.9% in the G-ER arm) and (n=191; 65% in the placebo arm). Patients in the G-ER arm had baseline hot flash frequency scores of 11.8, while placebo patients scored 12 for hot flash frequency. The baseline severity was 2.55 for patients in the G-ER arm and 2.54 for the placebo arm.

According to data from the study abstract, G-ER patients had a greater reduction in the last observation carried forward of hot flash frequency and severity at 4 weeks compared with placebo (mean reduction=–1.69; 95% CI, –2.29 to –1.08) and at 12 weeks (mean reduction=–1.14; 95% CI, –1.8 to –0.8) compared with placebo.

These reductions continued through 24 weeks, Pinkerton told Endocrine Today.

Pinkerton added that adverse events included dizziness, headache, somnolence and upper respiratory infections, but rapidly decreased over 3 weeks, much fewer than seen with shorter-acting gabapentin. However, Pinkerton maintained that G-ER was well-tolerated over the course of 24 weeks, with 5% more women discontinuing treatment over placebo. At the end of 24 weeks, more women were “much” or “very much” improved compared with placebo.

“Three out of 4 women have hot flashes. About 25% of patients report the hot flashes are bothersome enough to seek medical treatment and enough to affect their ability to work, sleep and function. There’s a cycle that develops, where severe hot flashes interrupt sleep, and patients develop fatigue and brain fog. It affects their ability to function at work and at home. What we want to do is interrupt that cycle by relieving hot flashes and improving sleep,” Pinkerton said.

If the drug is approved, Pinkerton said it could be available at the end of 2013. – by Samantha Costa

For more information:

Pinkerton JV. S-20. Presented at: The North American Menopause Society 23rd Annual Meeting; October 3-6, 2012; Orlando, Fla.

Disclosures: Pinkerton has served on advisory boards or review panels, received consultancy fees, grants, and/or has ties with various entities, including: Bionova, Depomed, Endoceutics, Merck, Noven, Novogyne, Pfizer, and Shionogi.