Treatment options for the dangerous condition known as obstructive sleep apnea (OSA) has evolved from continuous positive airway pressure (CPAP) devices to oral appliances and may soon include prescription medication.
In January, an advisory panel of the Food and Drug Administration (FDA) recommended approval of Qnexa, a medication being developed by Vivus Inc. for treatment of conditions including obesity, type 2 diabetes and OSA. Although the FDA is not bound by the advisory panel, it will consider the committee’s recommendation when it reviews the Qnexa application for regulatory approval later this year.
Specific to Qnexa’s potential for OSA treatment, a mid-stage trial of the drug indicated that Qnexa reduced the incidence of sleep apnea events in obese patients with OSA by nearly 70 percent.
In a 28-week study of 45 patients, Vivus reported that Qnexa resulted in a mean drop of apnea events from 46 per hour to 14 per hour. Patients also saw improvements in blood pressure and nighttime blood-oxygen levels, according to the California-based pharmaceutical company.
The most frequently reported side-effects were dry mouth, an altered sense of taste and sinus infections. However, Vivus has indicated that it would seek approval of Qnexa only for obese women who are not of childbearing potential and men; Qnexa is contraindicated for pregnant women and women who are planning to become pregnant, which means the drug should not be used because the potential risk outweighs the possible benefits for these patients.
If Qnexa is approved, it would be the first pharmaceutical to receive FDA approval for OSA treatment.
If you think you might suffer from OSA or another sleep disorder, a qualified dentist may be able to help. Please contact us to locate a dentist in your area with experience in diagnosing and treating sleep apnea and other sleep disorders.