Strongbridge Biopharma is preparing the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking the approval of Recorlev (levoketoconazole) for the treatment of patients with endogenous Cushing’s syndrome.
According to recent statements from the company, the NDA should be submitted to the FDA by the end of 2020, once the first findings from the company’s ongoing LOGICS Phase 3 trial (NCT03277690) are announced.
“During the first quarter of 2019, we held a Type C meeting with the FDA to seek their guidance on the regulatory pathway for Recorlev (levoketoconazole). In line with feedback from the FDA, we have concluded that submitting a New Drug Application (NDA) inclusive of data from both the Phase 3 SONICS and LOGICS studies is the optimal path forward,” Matthew Pauls, president and chief executive officer of Strongbridge Biopharma, said in a press release.
“The LOGICS study is progressing well; however, due to slower than anticipated enrollment, we now expect to receive top-line results by the end of the first quarter of 2020. Despite this shift in timing, we are pleased to report that with the additional clarity from the FDA and review of our timelines, we now plan to submit an NDA by the end of the third quarter of 2020,” Pauls said.
LOGICS is a multi-center, randomized, double-blind, placebo-controlled trial that has been designed to assess the safety, efficacy, tolerability, and pharmacokinetic properties of Recorlev in a group of patients with endogenous Cushing’s syndrome. Pharmacokinetics refers to the study of how a drug is absorbed, distributed, metabolized, and eliminated from the body.
The trial is recruiting patients who have never been treated with Recorlev, as well as those who participated in the company’s SONICS Phase 3 trial (NCT01838551), a study launched to evaluate the safety and efficacy of Recorlev for the treatment of patients with endogenous Cushing’s syndrome.
LOGICS’ primary outcome is to assess the effects of Recorlev withdrawal to placebo on the levels of cortisol in the patients’ urine, compared to patients who remained on Recorlev.
For patients who have never been treated with Recorlev, an open-label dose titration and maintenance phase lasting 14 to 19 weeks will determine the best dose of Recorlev for them. Then patients will enter the trial itself, where they will be randomly assigned to receive either Recorlev or a placebo for eight to 9.5 weeks (withdrawal phase).
This will be followed by a restoration phase, also lasting between eight and 9.5 weeks, in which patients receiving Recorlev during the withdrawal phase will continue treatment, while those who were on a placebo during the withdrawal phase will switch to Recorlev.
After announcing promising efficacy and safety data on Recorlev for the treatment of endogenous Cushing’s syndrome in SONICS, Strongbridge is now confident that LOGICS top-line results will bring additional evidence that will further support the submission of the NDA to the FDA.