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Strongbridge Biopharma rare disease drug meets main goal in phase 3 trial

Strongbridge Biopharma PLC said its drug Recorlev met the main goal of a late-stage study for treating endogenous Cushing's syndrome, a rare disease.

Cushing's syndrome — characterized by high blood pressure, weight gain, redness and fatigue — is caused by prolonged exposure to cortisol, a steroid hormone produced by the adrenal gland that regulates blood sugar and pressure. The endogenous type of the syndrome means the person is producing too much cortisol.

Under the 94-patient phase 3 study dubbed Sonics, 30% of the patients achieved normalization of mean urinary free cortisol after 6 months of maintenance treatment with Recorlev without having a dose increase.

The trial also saw statistically significant and clinically meaningful improvements in secondary goals from the patients, including improvements in fasting blood glucose, hemoglobin A1C, total cholesterol, low density lipoprotein-cholesterol, body weight and body mass index.

Meanwhile, 12 patients under the study stopped Recorlev due to adverse events. Another 14 patients reported one or more serious adverse events — four of whom were deemed drug-related by the trial's investigators.

Trevose, Pa.-based Strongbridge Biopharma plans to discuss with the U.S. Food and Drug Administration the potential for an accelerated approval for Recorlev.