The company founders of CounterAct, Dr. Todd Pizitz and Don Mealing, both have extensive professional experience in the substance abuse field.
Dr. Todd Pizitz, is a Clinical and Forensic Psychologist who specializes in the assessment and treatment of clients who struggle with substance abuse. Don Mealing, was founder and former CEO of American Corrective Counseling Services, which specialized in providing misdemeanor counseling diversion programs for courts and prosecutorial offices nationwide. More than half of all misdemeanor crimes are committed under the influence of alcohol or drugs.
In April, 2018, the Surgeon General of the United States issued a public health advisory urging families and friends to start carrying the opioid overdose-reversing agent Naloxone. Just last week, on October 23, 2018, the FDA Commissioner issued a statement announcing a two-day advisory committee meeting in December that will include a review of whether Naloxone should be co-prescribed with all or some opioid prescriptions. Some states like California, Arizona, and Vermont already have co-prescribing requirements with several others also considering this measure.
IANA Health’s Ashanthi Mathai recently had the opportunity to speak with Dr. Pizitz about the CounterAct Naloxone nasal spray cap that he and Don Mealing invented to fit on top of a standard prescription pill bottle.
Q: What motivated you to invent this device?
We have seen firsthand the difficulties people have with trying to control drug abuse, including opiate prescriptions, and we were appalled by the tens of thousands of overdose fatalities. As part of our conversations that Don and I had about taking up the FDA Challenge to come up with innovative solutions to help solve the opioid epidemic, we came up with the concept of the CounterAct Nasal Spray Cap. Don had lost three close relatives within the past 18 months to accidental opiate overdoses and that made us even more determined to pool our collective experiences and come up with a practical product solution to address one critical aspect of the opioid crisis, namely to prevent accidental overdose deaths.
Q: How do you see this device being different from other similar products?
The FDA has only approved one Naloxone nasal spray that has been saving hundreds if not thousands of lives, but this spray device has been more readily available to emergency medical responders and law enforcement.
Recently, with the Surgeon General’s suggestion that people carry Naloxone to help combat the opioid crisis, and co-prescription legislation in process, the idea of integrating the opiate medication with the overdose antidote emerged. Our concept was to combine a nasal spray device into the cap that snaps on to prescription pill bottles. This way, the patient and those in proximity to the patient have instant access to an overdose counter agent medicine.
Q: Would this device be anticipated for broad use or for specific situations?
We anticipate the CounterAct Cap will be something that resides in a patients’ medicine cabinet or on a bathroom shelf. Like a home fire extinguisher, it is there to use in case of an emergency. The design is very simple, and once it is inserted into a victim’s nostril, there is a single button that when pushed, automatically releases the emergency dose. Use instructions will be to call 911 and report the emergency, administer the spray, then wait for medical responders. We anticipate the scope of the CounterAct device will be mostly home use.
Q: Is there any information you could share about the regulatory pathway and timeline?
Our initial Regulatory Plan was accepted by the FDA in September of 2018. We are working on a 505(b)(2) regulatory pathway – The CounterAct Cap is a combination device since it contains and dispenses Naloxone. Our hope is to partner with pharma companies and co-develop our device. Once we begin our regulatory studies, we anticipate 18-24 months to complete our regulatory requirements.
Q: Based on your experience in the field, what are your thoughts on how best to contain the opioid epidemic going forward?
I believe greater policy alignment between Health, Law Enforcement, Legislators, Regulatory Agencies, and the General Public is the key to reducing the terrible level of opioid fatalities in America.
Doctors and clinicians must improve patient awareness over the serious-ness and the deleterious effect of taking too many opiates. Prescription patients must take responsibility for understanding risks and also take steps to protect themselves and those in their proximity from too-easy access to these powerful drugs. Patients also need more first aid awareness on what to do in case of overdose emergencies, as every second counts when attempting to save a life.
The company recently issued a press release following its successful meeting with the FDA which can be accessed here.