Lotus Pharmaceutical announced on the 8th that it has reached an exclusive licensing agreement with Supernus Pharmaceuticals, Inc. to acquire the market rights for Qelbree (viloxazine extended-release capsules), a medication used to treat attention-deficit hyperactivity disorder (ADHD). The agreement covers regions including South Korea, Taiwan, Hong Kong SAR, Indonesia, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam.

Lotus Pharmaceutical stated that Qelbree is an extended-release formulation of viloxazine, a novel non-stimulant drug for treating ADHD. The product has already been marketed in the United States as a prescription drug for treating ADHD in patients aged 6 years and older.

Based on the results of four key clinical trials, Qelbree was approved by the U.S. Food and Drug Administration (FDA) in 2021 for the treatment of ADHD in children aged 6 to 17 years. It was later approved in 2022 for treating adult ADHD. In March 2024, clinical trials for ADHD in children aged 4 to 5 years will commence.

Supernus recently completed a clinical trial of Qelbree’s impact on adults with ADHD and co-occurring mood symptoms, with the results set to be presented at scientific conferences.

Petar Vazharov, General Manager of Lotus Pharmaceutical, stated, “This agreement marks a significant step in our commitment to expanding access to innovative central nervous system therapies for patients in key APAC markets such as South Korea, Taiwan, Hong Kong, and Southeast Asia. We look forward to collaborating with Supernus and leveraging our expertise to bring Qelbree® to patients who need it the most.”

Jack Khattar, President and CEO of Supernus, stated, “Supernus is honored to extend the availability of Qelbree beyond the United States, helping patients facing the challenges of treating complex diseases like ADHD. Lotus Pharmaceutical’s dedication to providing innovative therapies makes them the ideal partner to expand Qelbree to other global markets.”

Resource: 美時與Supernus藥廠簽授權協議 獲過動症藥亞太市場權利