Methods for treating vasomotor symptoms using gaba analogs in a gastric retentive dosage form

Abstract

Methods for treating vasomotor symptoms associated with menopause are described.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. application Ser. No. 12 / 368,907, filed Feb. 10, 2009, now allowed, which claims priority under 35 U.S.C. 119(e) to the U.S. Provisional Application No. 61 / 065,442, filed Feb. 11, 2008, each of which is hereby incorporated herein by reference in its entirety.TECHNICAL FIELD[0002]The present subject matter relates to methods of treating a vasomotor symptom using gastric retentive dosage forms comprising a gamma-aminobutyric acid (GABA) analog. In a preferred embodiment, a method for treating one or more menopause-related vasomotor symptoms is provided.BACKGROUND[0003]Vasomotor symptoms of hot flashes, hot flushes, and night sweats are probably best known as being associated with female menopause. These vasomotor symptoms affect an estimated 75% of women aged over 50 years. However, these vasomotor symptoms may also be experienced, for example, by women undergoing breast cancer treatment with the an...

AI Technical Summary

Benefits of technology

The invention provides a method for improving sleep quality in a female subject suffering from menopause-related vasomotor symptoms such as hot flashes, by administering a gastric retentive dosage form of gabapentin. This dosage form reduces somnolence and other side effects associated with an immediate release dosage form. The method also includes a dose regimen to decrease the frequency and severity of vasomotor symptoms. Compliance with the treatment is improved as the gastric retentive dosage form reduces the side effects experienced with the immediate release form. Overall, the invention provides a more tolerable and effective treatment for our female subjects experiencing menopause-related vasomotor symptoms.

Problems solved by technology

Hot flashes significantly affect the quality of life for those who experience them, and are particularly bothersome at night as they can disturb sleep, leading to fatigue and lack of productivity during the day.

Unfortunately, these hormone therapies are inappropriate for patients previously diagnosed with breast cancer, as either estrogen or progesterone may be associated with an increased risk of cancer recurrence and are known to specifically promote growth of breast cancer cell with estrogen receptors.

Estrogen may also increase the risk of coronary and thromboembolic events during the first year of treatment.

Although the use of low dose estradiol therapy may diminish the risk for these large specialized patient populations, the risks of estrogen therapy are still great.

However, efficacy of these remedies is less than that of the hormone replacement therapies.

), and result in undesired side effects.

More recently, gabapentin use has been associated with the serious side effect of reversible visual field constriction (Bekkelund et al., Brit Med.

In studies involving use of gabapentin to treat menopausal symptoms, the prevalence of somnolence and dizziness side effects resulted in many women discontinuing use of the drug.

The need for t.i.d. dosing and unwanted side effects associated with immediate release gabapentin dosage forms may contribute to poor compliance for some patients in need of relief from vasomotor symptoms.

The above described side effects in this generally healthy population can be a considerable barrier to compliance with gabapentin therapy.

The complexity and length of the titration regimen may result in prematurely discontinuing therapy by patients prior to reaching the maintenance dose or to doctors preferring other therapeutic options.

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