Slenyto (melatonin) / Neurim - LARVOL DELTA

NEURIM PHARMACEUTICALS RECEIVES EUROPEAN MARKETING AUTHORIZATION FOR PEDIATRIC PROLONGED-RELEASE MELATONIN (SLENYTO) FOR THE TREATMENT OF INSOMNIA IN CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) (PRNewswire) - "Neurim Pharmaceuticals...announces that the European Commission has approved the extension of the indication to include the treatment of insomnia in children with attention deficit hyperactivity disorder (ADHD). The European Commission decision followed the recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2025."

EMA approval • Attention Deficit Hyperactivity Disorder • CNS Disorders

The revival of the mini-tablets: Recent advancements, classifications and expectations for the future. (PubMed, Eur J Pharm Biopharm) - "Most recently, two novel products with different concepts were authorized by the EMA and entered the market which are highlighted in this review: the first orodispersible mini-tablet with enalapril maleate for congenital heart failure (Aqumeldi® from Proveca Pharma) and the first single unit mini-tablet with matrix-type controlled melatonin release for insomnia (Slenyto® from Neurim Pharmaceuticals)...Film-coatings enabling gastric resistance, taste masking or sustained-release properties have been realized in both fluid-bed and drum coaters using the same polymers as for conventional tablets. There is still a significant lack in regulatory guidance despite the recent success of the mini-tablet concept, starting from suitable characterization methods in the pharmacopoeias up to the design and conduct of clinical studies on mini-tablets."

Journal • Review • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure • Insomnia • Sleep Disorder

NEURIM PHARMACEUTICALS RECEIVES POSITIVE CHMP OPINION ON SLENYTO (PEDIATRIC PROLONGED-RELEASE MELATONIN) FOR THE TREATMENT OF INSOMNIA IN CHILDREN WITH NEUROGENETIC DISORDERS (NGDs) (PRNewswire) - "Neurim Pharmaceuticals...announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending an extension to the existing indication to include the treatment of Insomnia in children with Neurogenetic disorders (NGDs)."

CHMP • CNS Disorders • Insomnia

Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine (clinicaltrials.gov) - P4 | N=165 | Completed | Sponsor: Ain Shams University | Recruiting ➔ Completed

Trial completion • Otorhinolaryngology

Efficacy and Safety of Slenyto for Insomnia in Children With ASD (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Neurim Pharmaceuticals Ltd.; N=104 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Autism Spectrum Disorder • CNS Disorders • Genetic Disorders • Insomnia • Sleep Disorder

Melatonin for insomnia in children. (PubMed, Med Lett Drugs Ther) - No abstract available

Clinical • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Pediatrics • Sleep Disorder

Evaluating the Efficacy of Adjunctive Therapies Used to Treat COVID-19: The Role of Famotidine, Melatonin, and Thiamine (Pharmacy Times) - "Famotidine is an H2RA that has been suggested as a potential adjuvant therapy for patients infected with COVID-19....Melatonin is another non-prescription agent that is being proposed as a potential adjuvant treatment for COVID-19 infection....Thiamine deficiency has been observed to be common in critically ill patients and has been linked to worse outcomes....Melatonin, and thiamine in the treatment of COVID-19 positive patients, their ease of access, relatively low price, and strong safety profiles makes them attractive choices as adjuvant therapies."

Review • Infectious Disease • Novel Coronavirus Disease

Best migraine supplements recommended by an expert (Migraine Again) - "Below is an excerpt from our 60-minute interview with Dr. Lipton where he was asked him about the effectiveness of various natural supplements....'If the extraction is not done right with butterbur, then there can be toxic alkaloids in it,' explains Dr. Lipton....'B2 is something I recommend [to my patients] very often,' says Dr. Lipton."

Interview