CTPharma, Yale embark on groundbreaking clinical medicines study

By Scott Benjamin

A growing pharmaceutical company and an Ivy League School of Medicine are collaborating on a groundbreaking clinical study utilizing medical marijuana that could result over time in putting a new tablet on the market to treat Post Traumatic Stress Disorder (PTSD) and be a solid substitute for opioids.

The Yale University School of Medicine in New Haven and Connecticut Pharmaceutical Solutions (CTPharma) of Portland announced in November that they have embarked on the first study approved by the state Department of Consumer Protection’s Medical Marijuana Research Program “to study stress and mental health issues,” according to a news release.

“With increasing levels of use of medical marijuana products in the U.S. today, it is imperative that we understand the science of how these products are working to alleviate patient symptoms,” Dr. Rajita Sinha of Yale University stated in the news release.

The clinical study may also address other conditions that may include PTSD and opioid replacement.

The Hartford Business Journal has reported that CTPharma is one of four licensed medical marijuana growers in Connecticut.

“The study’s initial phase is a safety and dosing study, in this case focused on pain and stress. The study will be the first of its type on human subjects, a double-blind randomized placebo-controlled clinical study using medical marijuana with an FDA-approved protocol,” according to the news release.

Tom Schultz, the president of CTPharma, said in a phone interview that nationally medical marijuana research is “not prevalent.”

However, “America has set the world’s pharmaceutical standards for the past century,” stated Rino Farraesee, the chief operating officer of CTPharma, stated in the news release.

But, “Today an English company has the only FDA-approved plant-based medical marijuana product on the market,” added Farraesee.

Schultz said that there is “absolutely” a possibility of other countries – such as England, Italy and Germany – could take the lead away from the United States in pharmaceutical research in this area.

Schultz, a native of New Britain who got his bachelor’s degree from Yale, said Connecticut is an ideal place for the research because of the capabilities of the Yale School of Medicine and the support the project has received from state officials.

He said many people in Connecticut “are comfortable with having medical marijuana research.”

Schultz said that CTPharma applied for a license in 2012, submitted a formal request for the research in 2014 and the General Assembly authorized the project in 2016.

“There has been little resistance in Connecticut,” he said. “We’re grateful to be here.”

In 2017, the federal Food & Drug Administration approved the investigative new drug protocol that was presented by Yale University and CTPharma.

Shultz, who has a law degree from New York University, said he legal skills have been utilized in navigating the project through the various phases, particularly in getting approval from the federal Food & Drug Administration.

The news release stated that the first study would consist of adult men and women ages 21-45 who are recreational marijuana users but do not meet criteria for cannabis use disorder. They will complete six separate inpatient laboratory sessions one week apart during which they will be assigned to receive placebo or acute doses.

The second study will consist of adult men and women ages 21-60 with chronic pain (not fully-controlled by opioid pain medication). They will be recruited and randomly assigned to receive the most tolerable CBD/THC dose or placebo repeated dosing for 7 days,” according to the news release.

Schultz said “the small number of people size of the samples are typical for studies of this type and that other questions can be considered later.”

He said the research could eventually lead to “targeting it to get more specific and focused,” including addressing such conditions as muscular dystrophy and cancer.

After completing the needed studies, Schultz said it would likely take three to seven years before a new drug would be on the market.

Fox CT 61 in West Hartford reported that state Department of Consumer Protection Commissioner Michelle Seagull has said that in Connecticut medical marijuana is serving over 40,000 patients and there are more than 1,000 certifying practitioners.

WTNH Channel 8 in New Haven, an ABC affiliate, has reported that initially medical marijuana was legalized to treat 11 specific conditions in Connecticut and has since expanded to 36 and another 10 for people 18 years of age and younger.

Schultz said he believes there is considerable opportunity for growth in Connecticut in the pharmaceutical industries due to the research facilities available and the support of state officials. Former Lt. Gov. Michael Fedele of Stamford is chairman of CTPharma’s Board of Directors.

Schultz said, “I’m not going to hold my breath for the growth of manufacturing.”

Connecticut reportedly saw its manufacturing base sliced in half between the early 1980s and the early 2000s.

However, some state officials believe there will be many additional advanced manufacturing positions over the coming years following long-term commitments by the major defense contractors in the state – Lockheed Martin at the Igor Sikorsky helicopter plant in Stratford; United Technologies at the Francis Pratt and Amos Whitney jet engine facility in East Hartford; and General Dynamics at the Electric Boat submarine shipyard in Groton.

Schultz said CT Pharma will soon about double its 44-employee roster when it moves from its 15,000-square-foot facility in Portland to a 173,000-square-foot complex in Rocky Hill that formerly housed the McKesson Corporation pharmaceutical firm.

Gov. Ned Lamont (D-Greenwich) and former Gov. Dannel Malloy (D-Essex), Lamont’s immediate predecessor, have identified the pharmaceutical industry as potential growth area in a state that is the only one in New England that hasn’t recaptured all of the jobs lost during the 2008 recession.

Boehringer Ingelheim, a major German-based pharmaceutical company, arrived in Ridgefield in 1971, expanded to just over the border to Danbury in the early 1980s and has gone through several expansions through the years as the company’s North American research center and become one of the largest employers in the Hat City.

Former independent gubernatorial candidate Oz Griebel of Hartford has told Patch.com that Yale’s medical research has made New Haven a different city than it was 20 years ago as there have been more avenues for health care and bioscience development.