Revolutionizing CNS Treatments through Nanomedicine
MVK Pharmaceuticals is an early-stage drug development company that has completed positive preclinical trials and is in the process of submitting an IND package to the FDA to begin Phase I human studies. The company seeks to advance a first-in-class treatment of suicidal ideation with major depression through intranasal delivery of a three amino acid neuropeptide loaded in a biodegradable nanoparticle. Success will launch a pipeline of drugs for various treatments that range from PTSD, TBI, anxiety, sleep, addictions, epilepsy, and other disorders.
IND Submission for Phase I Human Trials
MVK Pharmaceuticals is preparing a FDA IND packet for the indication of Major Depression with Suicidal Ideation. The company will request Fast Track designation and plans to submit in 2017.
Major Depression with Suicide Ideation
Studies in 2013 by the CDC found that an estimated 9.3M adults aged 18 years and older in the US reported having suicidal thoughts. An estimated annual average of 2.7M adults in the US report having made suicide plans in the past year and 1.1M attempted. Of those that attempted, 0.9M had plans and 0.2 did not and over 41,000 completed their suicide attempt.
We lose 22 veterans per day in the US and MVK Pharmaceuticals has elected to do something about it. Through a DoD grant from 2012, clinical trials in patients with major depression and suicidal ideation are planned to begin in 2017 to help with this growing epidemic in the DoD, VA, and civilian populations.
Within a given year, 8 million US adults develop post-traumatic stress disorder (PTSD) and an average between 7-8 people out of 100 will develop PTSD within their lifetime. At the heart of PTSD is a traumatic event and for the military this means combat. It is estimated that 11-20% of the OIF and OEF veterans, 12% of Gulf War veterans, and 15% of Vietnam veterans have PTSD in a given year,
MVK Pharmaceuticals is committed to advancing current treatments for PTSD hallmarked by anxiety, depression, drug and alcohol abuse, and sleep disorders.
Approximately 3,000 babies are born per year in the US with Infantile Spasms. Infantile spasms are characterized by clusters of sudden contractions that occur up to 100 times per day that begin between 3 and 8 months and last until the child is 2 to 4 years old. Current medications for infantile spasms have side effects that include: visual filed restriction, intellectual disability, and Cushing’s Syndrome, just to name a few.
MVK Pharmaceuticals intends to investigate compounds that are both clinically effective and allow the child to develop with reduced side effects.
MVK Pharmaceuticals in the Media
CURE Citizens United for Research in Epilepsy
Dr. Michael Kubek recieves the Rhode Island Award for 'Intranasal Delivery of Sustained-Release Anticonvulsant Neuropeptide Nanoparticles in Seizure Therapy'
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