Circadin® 2mg prolonged-release melatonin formulation, approved for use (up to 13 weeks) in treatment of primary insomnia characterized by poor quality of sleep in patients aged 55 years or over.
Circadin® has been approved by several agencies globally, including the European Medicines Agency (EMA), the Australian Therapeutic Goods Administration (TGA), the Swiss Agency for Therapeutic Products (SwissMedic) and the Israeli Ministry of Health (MOH). The approval is based on clinical studies demonstrating positive effects on sleep quality, sleep induction, and most importantly next day alertness and functioning. Read more
Products in Clinical Phase
Paediatric Prolonged-Release Melatonin (“PedPRM”)
Paediatric Prolonged-Release Melatonin is a novel formulation under development, for sleep disorders in children with neurodevelopmental disabilities that have difficulties swallowing. For this purpose, Neurim Pharmaceuticals has developed an age‐appropriate oral solid dosage form of prolonged-release minitablets, 3mm in diameter.
PedPRM has been designed to gradually release melatonin, mimicking the physiological secretion profile of melatonin that produces sustained plasma levels of melatonin for up to 8-10 hours.
Paediatric Prolonged-Release Melatonin has successfully completed a Phase III clinical trial in neurodevelopmental disabled children suffering from sleep disorders. It met the primary efficacy endpoint demonstrating statistically significant improvement in total sleep time (TST) compared to placebo. In addition to TST, secondary efficacy endpoints demonstrating improvements in sleep initiation and maintenance were also met. Safety profile was similar between PedPRM and placebo-treated groups.
Neurim is moving forward with regulatory submissions for this product.
Piromelatine is a novel compound under development for sleep and cognition in treatment of insomnia and Alzheimer’s Disease.
Piromelatine is an agonist of melatonin receptors and serotonin 5-HT-1A and 5-HT-1D receptors. Through its action at MT receptors, Piromelatine may improve circadian rhythms control, metabolism and sleep and through the serotonergic mechanism improve memory and mood. MT and 5HT1a mechanisms synergistically enhance neurogenesis and neuroprotection.
This multi-targeted drug candidate has already demonstrated efficacy and safety in a Phase II clinical trial in patients with primary insomnia. Based on preclinical studies in cell and animal model of the disease, Neurim intends to study the efficacy and safety of Piromelatine in patients with mild to moderate Alzheimer’s Disease. Piromelatine’s multi-targeted mechanism of action is different from that of Alzheimer’s Disease medications and from investigational failed drugs. Read more
Neu-P12 is a multi-facetted new chemical entity with analgesic potential.
Its mechanism of action involves inhibition of human Nav1.7 sodium channels and TRPV1 non-selective cation channels that are widely expressed in skin tissues, and peripheral sensory nerve fibers. Neu-P12 does not interact with COX 1 or 2 or opioid receptors, suggesting a selective mode of action. It demonstrates a good potential for the treatment of inflammatory and pain in three different and relevant animal pain models.
Neu-P12 is intended as a therapy for neuropathic pain and is currently in Phase I at First in Human stage.
Products in Preclinical Phase
Neu-240 is a potent and selective uncompetitive NMDA receptor modulator aimed at improving motor control. Neu-240 is a derivative of Neu-120, intended for use as adjunct therapy to levodopa in patients with Parkinson’s disease and is currently at the preclinical stage.