Neurim Pharmaceuticals, founded and managed by CEO Nava Zisapel, has announced a successful Phase III trial for improving sleep among children on the autistic spectrum. PedPRM, the company's product, is a medical version of melatonin. The company's drug is released gradually throughout the night. In the trial, the company demonstrated that its product enabled children to fall asleep more easily, and increased the number of hours they slept.
Zisapel said, "It is known that children on the autistic spectrum suffer from damage in their melatonin creating mechanism. It is apparently this damage that contributes to both their cognitive symptoms and their sleep disturbances. Up until now, there has been no pharmaceutical treatment for these children. Adult sleep medications were found to be ineffective and unsafe for them."
Neurim Pharmaceuticals is already marketing the Circadin sleep medication, also based on delayed release melatonin, for adults who sleep too little at night and wake up too early. Revenue from sales of this product, which is in the tens of millions of dollars a year, comes from partners, including Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) in Israel and international pharma company Takeda in Europe.
Zisapel noted that the trial for PedPRM was also conducted in the US, and the company was taking steps to register it there. Melatonin can currently be purchased in the US as a food additive, but Zisapel says that while the additive was successful at inducing sleep, it does not increase the number of hours of night sleep for either adults or children. She added that the additive did not require the quality control needed for a medical product.
PedPRM was tested as a drug for all intents and purposes. "The trial cost tens of millions of dollars," Zisapel stated.
Published by Globes [online], Israel business news - www.globes-online.com - on November 2, 2016
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