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New weight loss drug Qsymia wins local approval
  • By Lee Hye-seon
  • Published 2019.08.01 10:57
  • Updated 2019.08.01 10:57
  • comments 0

The local drug regulator has approved a new obesity treatment, Qsymia Cap. (ingredient: phentermine/topiramate), giving more options to obese people.

However, the use of Qsymia is likely to be limited because regulators categorize it as a psychotropic drug. Physicians must report the prescription of Qsymia to the government’s narcotics information management system.

The Ministry of Food and Drug Safety on Wednesday granted the sales license of Qsymia, a combination of popular appetite suppressant phentermine and epilepsy treatment topiramate.

Phentermine is the most commonly prescribed weight loss treatment in Korea. Topiramate treats epilepsy, stimulates energy metabolism and controls appetite. Both ingredients are psychotropic medications.

The combo of phentermine and topiramate raises the effect of appetite suppression, and doctors often prescribe them together. Whereas other diet medications require short-term use, Qsymia is available for long-term use.

Qsymia’s side effects include numbness in hands and feet, dizziness, and cognitive impairment. Patients should avoid taking the drug in the evening because it may cause insomnia. The medicine also may cause acute visual loss or eye pain with an extremely low probability.

Pregnant women, glaucoma patients, and patients with hyperthyroidism should not use it.

Regulators have authorized Qsymia Cap. for adults with a body mass index (BMI) of 30 or above, or a BMI of 27 or higher with at least one weight-related condition, such as hypertension, type-2 diabetes, or dyslipidemia. As it is a combo of two agents, patients should not use it with another appetite suppressant and must use it alone.

The local approval of Qsymia adds another option of obesity treatment but the drug’s status as a psychotropic medicine, subject to reporting to the Narcotics Information Management System, is likely to limit prescriptions.

Unlike in 2017 when Alvogen Korea signed a deal with Qsymia developer Vivus to own the local sales rights, the government recently tightened regulations on narcotics-based medicines. The food and drug safety ministry is monitoring excessive prescriptions of such drugs by analyzing big data.

The ministry said Tuesday it would disclose information of prescriptions of diet drugs by analyzing the big data of the narcotics information management system, and sent the analysis results to physicians who prescribed weight loss treatments more than the average via mail.

Pharmaceutical industry officials said the weight loss treatment market has shrunk since the government introduced the narcotics information management system.

“With the introduction of the system, the size of the appetite suppressant market has gotten smaller. Even if a new weight loss drug gets released, it will find it difficult to enter the market because of the conventional drugs’ solid sales,” an industry executive said.

lhs@docdocdoc.co.kr

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