New Data From Phase 3 Cushing’s Syndrome Trial Presented

According to a story from globenewswire.com, the biopharmaceutical company Strongbridge Biopharma plc, recently presnted a new analysis of data from the company’s Phase 3 trial. This trial was testing the company’s product RECORLEV™ (active ingredient levoketoconazole) as a treatment for endogenous Cushing’s syndrome. Endogenous in this context means disease caused from an internal change, not an outside source. An earlier analysis of findings from this trial had previously been presented, and new findings are continuing to reveal more information about how RECORLEV could positively impact patients with Cushing’s syndrome.

About Cushing’s Syndrome

Cushing’s syndrome is a medical condition that appears as the result of prolonged cortisol exposure. Cushing’s syndrome is most commonly caused by the use of medications such as corticosteroids, but it can also be caused by abnormalities that cause the body to release more cortisol than usual, such as a tumor affecting the pituitary or adrenal glands. Cushing’s syndrome is also associated with diabetes, which is a common comorbidity. The syndrome can cause a variety of symptoms that can become more serious over time including cerebral atrophy, hypercholesterolemia, rapid weight gain, baldness, mood instability, depression, hirsutism, sexual dysfunction, muscle and bone weakness, menstrual abnormalities, osteoporosis, diabetes, hypertension, sleep problems, and immune system suppression, and memory problems. Treatment may include the cessation of drug use when they are the cause, surgery to remove tumors or affected glands, or certain drugs that inhibit cortisol synthesis. To learn more about Cushing’s syndrome, click here.

New Discoveries

This new presentation, which was made at the Annual Meeting of the Endocrine Society (held from March 23-26), focused on the impact of RECORLEV on patients that presented with both Cushing’s syndrome and diabetes. The analysis of this subgroup indicates that these patients saw comparable reductions in cortisol compared to other patients. However they also saw positive changes in certain other endpoints as well, such as cholesterol levels, fasting blood glucose, and hemoglobin A1c. Safety profiles in this subgroup were also unchanged from the overall participant data, and no major concerns in this area were noted.

These findings suggest that RECORLEV has the potential to be a useful treatment for endogenous Cushing’s syndrome.

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