"This will fill an unmet need in mental health," says Tom Dooley, PhD, a Birmingham researcher with 13 patents for pharmaceutical and biotech developments to his name.
Dooley was issued his latest of two U.S. patents in December to cover novel drug combinations for the fast-acting, as-needed treatment of anxiety disorders. He had previously focused his research on dermatology and oncology, until a family member started experiencing anxiety issues in 2007, which helped stimulate the concept for this invention.
Typically, the 40 million people over the age of 18 who suffer from anxiety disorders rely on benzodiazepines, such as Xanax, to quiet the symptoms of acute anxiety and panic attacks. This class of drugs can show effects within a half hour and comes with side effects and FDA warnings of potential for abuse. According to The Royal College of Psychiatrists, about four in every 10 people who take benzodiazepines daily for more than six weeks will become addicted.
In the course of watching his family member take benzodiazepine, Dooley became intent on finding an alternative. "I didn't like seeing the side effects such as drowsiness and impaired cognition," he says. "And I decided somebody had to come up with something better."
The result is PanX. "This is not one drug. This has the potential for being hundreds of drug combinations," Dooley says. "In sublingual form, it could offer relief within 15 minutes and the active ingredients are non-addictive."
The multitude of medicinal options derives from PanX being a combination of two active ingredients, one pulled from beta blockers and one from antiemetic antimuscarinic agents -- two classes of historically-safe and non-addicting active ingredients.
In a panic attack, the beta blocker interferes with adrenaline and addresses the cardiovascular symptoms of anxiety, such as increased heart rate and blood pressure. "That stops the racing heart which is the number-one symptom of an acute anxiety episode. I needed some active ingredient to do that," Dooley says. "And I needed to marry it with something that would help with the anxiousness, fear, avoidance, nausea and sweating."
That turned out to be antiemetic antimuscarinic agents, commonly used to treat motion sickness and nausea. These address the non-cardiovascular and central nervous system symptoms of anxiety. "The combination is designed to suppress the multiple diverse symptoms of panic attacks or acute anxiety episodes," Dooley says.
Because PanX pulls from two classes of medications, it offers the advantage of a wide array of choices in active ingredients to suit patients. "You can combine any active ingredient from one class with any active ingredient from the other," Dooley says.
That can solve many comorbidity dilemmas, such as with anxiety patients who might be prone to asthma and need to avoid certain beta blockers such as propranolol.
The flexibility of PanX extends to choosing the potency of the active ingredients as well, and even the taste. "Some drugs just taste bad, but PanX lets you choose ingredients with taste, if you want something sublingual," Dooley says. "One could envision many different ways to make the products, even for the same patient."
Professor Charles Nemeroff, MD, PhD, Chairman of the Department of Psychiatry at the University of Miami stated in a PanX release, "A number of patients with anxiety symptoms do not respond or cannot tolerate currently available treatments. This novel approach combining two medications with distinct mechanisms of action has the potential to fill an important niche in the management of such patients."
The multitude of combinations categorizes PanX as new class of drugs. "Patents in pharmacology are typically very narrow -- usually one active ingredient in a specific route of delivery and specific potency. This patent is extremely broad," Dooley says. "This is a class of anxiety medications, like opioid painkillers are a class of drugs."
Dooley has already produced a handful of prototypes with the goal of clinical trials once sufficient investment funds are raised, which is currently underway. "We plan to sell products that are FDA approved or even over-the-counter," he says. "But for now, we can sell PanX for patients, even for pets, as compounded pharmaceuticals, because the active ingredients are off-patent and are historically well known and already present in FDA-approved drugs."
Unlike so many new drugs on the market, Dooley says PanX will remain affordable. "We're not talking ridiculous prices. Our goal is to have something to cause a calming effect rapidly but affordably," he says. "And readily handy."
Whereas benzodiazepines are typically prescribed as daily preventive medications, PanX is intended to be put in a pocket for occasional use as needed. "If you know you have an event that will trigger your symptoms, you can take it and have rapid relief of your symptoms," Dooley says.