PANTHERx Rare Pharmacy to Distribute Recorlev Therapy in US
Xeris Pharmaceuticals has selected the specialty pharmacy PANTHERx Rare to distribute Recorlev (levoketoconazole), the company’s therapy that was recently approved to treat adults with endogenous Cushing’s syndrome in whom surgery is not possible or not effective.
“As the sole pharmacy for Recorlev, PANTHERx recognizes the importance of outstanding execution in order to deliver innovative medication, customized support services, and hope to this vulnerable patient population,” Snyder added.
According to PANTHERx, the medication is expected to be commercially available to patients within the next month or two.
Cushing’s syndrome is caused by abnormally high levels of cortisol, a hormone that the body normally produces in response to stress. Cushing’s disease is a specific form of the syndrome in which high cortisol levels are caused by a tumor in the brain’s pituitary gland.
The first line of treatment for Cushing’s is surgery to remove the disease-driving tumor. However, surgery is not an option for some people, and it may not always completely resolve Cushing’s symptoms. Recorlev is indicated to help manage symptoms in these cases, and it works by blocking the production of cortisol.
The U.S. Food and Drug Administration (FDA) approved Recorlev for this indication late last year. The approval was supported by data from two Phase 3 trials, SONICS (NCT01838551) and LOGICS (NCT03277690), which collectively enrolled 166 participants with Cushing’s.
Trial results demonstrated that Recorlev could lower urine cortisol levels in about a third of treated participants to a normal range. Consistently, withdrawing the medication led to an increase in cortisol levels.
Trial data further showed that the medication lessened Cushing’s symptoms, eased depression, and improved quality of life. Findings also indicated Recorlev may aid in controlling diabetes, reducing the risk of heart disease, and lowering levels of cholesterol and body fat.
Approval also was supported by data from an ongoing open-label trial, called OPTICS (NCT03621280), which is evaluating the safety and effectiveness of Recorlev in patients treated for up to three years.