Melatonin for children: no additional benefit for slenyto – pharmacy adhoc

Berlin – Next setback for PUMA approvals: The Institute for Quality and Efficiency in Health Care (IQWiG) sees no additional benefit for the pediatric drug Slenyto (melatonin, Infectopharm). It was only in November that the Federal Joint Committee (G-BA) certified that the pediatric preparation Alkindi (hydrocortisone, Diurnal) had no additional benefit.

PUMA stands for Pediatric Use Marketing Authorization and is issued for drugs that are already approved for use in adults and for which further approval is only requested for the treatment of children. Slenyto is approved for the treatment of sleep disorders in children aged two to 18 years with autism spectrum disorders or Smith-Magenis syndrome when sleep hygiene measures do not provide adequate relief. The slow-release melatonin mini tablet is tasteless and odorless.

The G-BA commissioned IQWiG to assess the benefit of the pediatric medicinal product. Best Supportive Care (BSC) was determined as the appropriate comparative therapy. By definition, this is the best possible, patient-optimized, supportive treatment that is used to alleviate symptoms and improve quality of life. In the case of Slenyto, further psychotherapeutic measures would be suitable according to the benefit assessment. And I agree This is the problem: Although the manufacturer has also defined the BSC as a useful comparative therapy, IQWiG writes that the versions are sufficiently implemented in the placebo control. "This restriction is not appropriate."

Slenyto was studied in a double-blind, placebo-controlled phase III study and an open follow-up study. The results confirm the drug’s effectiveness in both short and long-term use. According to Infectopharm, long-term data from two years of use were collected in 24 centers in the EU and the USA. 125 children aged two to 17.5 years with sleep disorders and autism spectrum disorder or Smith-Magenis syndrome were randomized – 28.8 percent with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and 12.8 percent with comorbid epilepsy. Treatment was independent of age with 2 mg melatonin. If the response was insufficient, the dose could be increased from 2 to 5 mg in week 3 and from 2 to 5 mg or from 5 to 10 mg in week 26.


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