Sunosi (ingredient: solriamfetol), a treatment for narcolepsy developed by SK Biopharmaceutical and licensed-out to Jazz Pharmaceuticals, had been a failure, an executive at SK Biopharmaceutical said.
Park Jung-shin, vice president of SK Biopharmaceutical for clinical research, shared the story behind the development of Sunosi when she spoke on a non-clinical trial strategy in central nervous system drug development at a workshop in Osong, North Chungcheong Province, Wednesday.
|Park Jung-shin, vice president of SK Biopharmaceutical for clinical research, speaks on a non-clinical trial strategy in central nervous system drug development, at a workshop in Osong, North Chungcheong Province, Wednesday.|
Korea’s National Institute of Food and Drug Safety Evaluation (NIFDS) and the Drug Information Association (DIA) of the U.S. jointly hosted the workshop.
Sunosi is the first central nervous system drug developed by a Korean company that received approval from the U.S. Food and Drug Administration (FDA).
SK Biopharmaceutical completed the phase-1 trial on Sunosi and agreed to give the global sales rights to Jazz Pharmaceuticals, which specializes in sleepiness treatment, in 2011.
Jazz Pharmaceuticals obtained the license from the FDA in March based on phase-3 data and released the product in the U.S. on July 8.
According to Park, SK Biopharmaceutical had initially been developed Sunosi as a treatment for depression and licensed it out to a multinational drugmaker. However, the multinational firm saw a low chance of developing it as a depression treatment during a trial and returned the development right back to SK Biopharmaceutical, she said.
After the completion of the phase-1 study on Sunosi, SK Biopharmaceutical licensed out the agent to Johnson & Johnson in 2000. However, the two nullified the deal because of no efficacy in a trial.
“Companies tend to make a decision based on pre-clinical data before entering a trial in earnest. This is because each clinical stage costs a lot. When we looked into Sunosi’s data, we confirmed that it had a side effect of insomnia,” Park said. “We had portfolio meetings internally to discuss how to save this drug.”
After a series of internal meetings, the company decided to develop Sunosi as a drug to prevent excessive daytime sleepiness in patients with obstructive sleep apnea. The company reorganized its data and looked for a third partner, Jazz Pharmaceuticals.
Park also shared information about abuse data, which the company submitted to the FDA during Sunosi approval process. The FDA strictly reviews abuse data of central nervous system drugs.
“If a company develops a central nervous system drug, it must submit data related to drug abuse to the FDA during the New Drug Application process,” she said.
While Korea classifies central nervous system drugs as psychotropic, the U.S. classifies them into five “schedules,” Park noted. Those with Schedule 1 have a high potential for abuse, and those with Schedule 4 or 5, a low potential. Amphetamine is classified as Schedule 2, and Sunosi, Schedule 4.
“Internally, the company had expected that Sunosi would get Schedule 5 due to the significantly low potential for abuse, compared to Amphetamine. But the FDA took a more conservative view,” she said.