SAN DIEGO, Oct. 4, 2018 /PRNewswire-PRWeb/ --
- Meeting with FDA confirms company's regulatory pathway
- Human Factors Clinical data requirements would be limited to Bio-Availailability study of the selected Naloxone formulation
- Proposed spray characteristics for the device component of the product agreed upon
- Proposed Human Factors Studies were agreed upon
In September, 2018 CounterAct received a positive response from the United States Food and Drug Administration (FDA), enabling further development of a patent-pending nasal spray device to be used as a potential new method to administer life-saving Naloxone to opioid overdose victims.
This development is a critical milestone and demonstrates that FDA regulatory authorities have examined and approved CounterAct's regulatory strategy and pathway.
Co-Founders, Dr. Todd Pizitz and Don Mealing state they have received very specific FDA directives that establish a clear and concise roadmap for the development of the CounterAct overdose nasal spray cap. "The results from this latest FDA Review was very encouraging and we are ready to begin the regulatory pathway," said Dr. Pizitz.
CounterAct's cap design is simple, and serves as an ideal "Home Use" emergency first aid product that can be administered by family members, friends, or associates that may encounter an overdose victim before 911 Overdose Responders arrive on scene.
CounterAct hopes to save many more lives from accidental overdose once it obtains FDA approvals.
On September 10, 2018, California became the latest state to pass Co-Prescription Legislation that requires an emergency dosage of Naloxone to be prescribed whenever doctors prescribe certain opioid drugs to their patients. CounterAct hopes to meet this demand as California and other states enact this law.
CounterAct's product development focus is on the opioid prescription population, not illicit drug users. Prescription opioids continue to contribute to the opioid overdose epidemic in the United States. From 1999 to 2016, more than 200,000 people died in the U.S. from overdoses related to prescription opioids. Overdose deaths involving prescription opioids were five times higher in 2016 than 1999. , More than 40% of all U.S. opioid overdose deaths in 2016 involved a prescription opioid, with more than 46 people dying every day from overdoses involving prescription opioids.
For more information Contact: noscounteract.com
Co-Founder Todd D. Pizitz, Ph.D.
(619) 507-7907
[email protected]
Co-Founder Don Mealing
(949) 660-9900
[email protected]
SOURCE CounterAct
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