non-cardiac chest pain

Study Suggests Dronabinol Effective for Treating Non-Cardiac Chest Pain

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New research suggests that dronabinol, a cannabinoid receptor activator, could serve as a novel approach to treating non-cardiac chest pain due to esophageal hypersensitivity.

Not all chest pain comes from the heart. Each year, an estimated 200,000 Americans experience non-cardiac chest pain, which in addition to pain can involve painful swallowing, discomfort and anxiety. Since non-cardiac chest pain can cause painful symptoms that mimic a heart attack, patients often get scared and go to the emergency room. However, non-cardiac chest pain often originates in the esophagus.

Currently, treatment for non-cardiac chest pain includes pain modulators, such as selective serotonin reuptake inhibitors (SSRI), which only has a partial 40 to 50 percent response rate in alleviating symptoms.

New research, authored by Ron Schey, MD, FACG, gastroenterologist at the Temple University Hospital, suggests that treatment with dronabinol, which traditionally has been used to treat nausea and vomiting in HIV patients and cancer patients undergoing chemotherapy, may offer a new approach to treating non-cardiac chest pain.

Dr. Schey and his research team conducted a pilot study involving 13 patients with non-cardiac chest pain. They found that those who were given 5 mg of dronabinol twice-daily for four weeks fared better than patients who took a placebo. Those receiving dronabinol experienced improved pain tolerance and decreased frequency and intensity of chest pain. Additionally, no significant adverse effects were reported.

“This novel study has promising findings in future treatment for these patients,” said Dr. Schey, Associate Professor of Medicine at Temple University School of Medicine, who conducted the research while on staff at the University of Iowa Hospitals and Clinic, and analyzed data at the Temple along with Zubair Malik, MD, a first-year fellow in Temple’s Division of Gastroenterology.

According to Dr. Schey, despite encouraging results, the pilot study was very small and not designed to test dronabinol against current therapies available for non-cardiac chest pain, therefore it is difficult to calculate how the drug performs in comparison to existing treatments. Dr. Schey said that a larger scale study on the effects of dronabinol on non-cardiac chest pain will begin soon at Temple.

The abstract was presented on Monday in Philadelphia at the Annual Scientific Meeting of the American College of Gastroenterology.

Source: Temple Health

Last updated: 10/21/14; 2:40pm EST

Insys Therapeutics

Insys’ Application for Dronabinol Oral Solution Rejected by the FDA

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Insys Therapeutics recently announced that the US Food and Drug Administration (FDA) has rejected its application for Dronabinol oral solution for submitting an inadequate or incomplete pediatric study plan.

The company said that it received a Refusal to File Letter from the agency for its New Drug Application (NDA) for its proprietary Dronabinol oral solution, causing shares to fall about ten percent. Insys said that it believes that the information required is available, and the company will not need to conduct further clinical studies to address the pediatric study plan requirement.

Insys had filed the NDA for the oral solution in August 2014. The company said that it is working closely with the FDA to resubmit the NDA as quickly as possible.

“We will work closely with the FDA to fully address the incomplete pediatric study plan and define a path forward for a successful resubmission of this NDA as soon as possible,” said Michael L. Babich, President and Chief Executive Officer of Insys. “We have had constructive dialogue with the FDA throughout this process and we are confident in our ability to address the agency’s request and resubmit rapidly as we believe no additional studies are required to address the incomplete pediatric plan, which was the only item cited as the cause for the refusal to file.”

Separately, Insys said that its FDA-inspected and Drug Enforcement Agency (DEA) approved facility in Round Rock, Texas has received DEA approval to manufacture synthetically its pharmaceutical grade Cannabidiol (CBD). The company has been cleared to manufacture up to 15 kilograms of CBD in 2014, and expects that number to increase in 2015 for its continued clinical studies.

Insys intends to file an investigational new drug application in December for use of its CBD in patients with two rare forms of pediatric epilepsy, Dravet syndrome and Lennox-Gastaut syndrome.

“We are excited to initiate our clinical development of CBD in these pediatric patients, for whom current treatments are insufficient. We plan to dose our first human subject in the first quarter of 2015 in a Phase I setting,” said Insys’ President and Chief Executive Officer, Michael L. Babich. “Numerous investigators are waiting to receive our finished pharmaceutical dosage product to study several other potential indications for CBD. With DEA approval to manufacture CBD in hand, we are now in a position to supply product to these investigators.”

Source: Insys Therapeutics, Inc.

Last updated: 10/21/14; 11:40am EST

Cannabics Pharmaceuticals Inc.

Ministry of Health in Israel Grants Cannabics Pharmaceuticals Cannabinoid R&D Lab Certification

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Cannabics Pharmaceuticals Inc. recently announced that it has received Government Certification from the Ministry of Health in Israel for establishing an advanced Research and Discovery laboratory dedicated to medical research in the cannabinoid science field.

US-based Cannabics Pharmaceuticals, founded in 2012 by a group of researchers from the fields of molecular biology, cancer research and pharmacology, is a development company focused on the development and commercialization of advanced drugs, therapies, food supplements and administration routes based on the wide range of active ingredients found in diverse and unique strains of the Cannabis plant. The company’s goal is to be one of the first few companies in the world to commercialize indication specific and clinically tested cannabis-based medical products.

Cannabics is currently in advanced preparations for the launch of a series of clinical studies in leading medical centers in Israel, where the company’s R&D division is located. Its new cutting-edge laboratory is designed to employ novel technologies intended for developing innovative cannabinoid-based therapies for various debilitating conditions.

“The exciting scientific field of cannabinoid research has been largely neglected throughout most of the 20th century due to a total ban on this field of research. Thus, the available scientific knowledge regarding active cannabinoids and their mechanisms of action in various disease pathways is dramatically lacking in comparison to other therapeutic fields. There is a huge space of uncharted territory to explore with regards to the potential therapeutic roles of this class of compounds for diverse indications,” said De. Zohar Koren, CEO, Cannabics Pharmaceuticals.

The company said that it is especially interested in developing cannabinoid-based therapies for treatment of cancer. Cannabics’ current flagship product is CANNABICS SR, an IP pending medical cannabis capsule designed specifically for cancer patients as a palliative care treatment. In observational studies, the company’s proprietary SR technology has shown the ability to provide 10-12 hours of steady state beneficial therapeutic effects profile, and thus allows for a convenient oral once-per-day dosing regimen of medical cannabis for patients.

“The unique properties of active cannabinoids as tumor cell proliferation inhibitors and apoptosis inducers has been known for decades, however this field has never received the appropriate scientific attention it deserves as a potential source for anti-cancer therapies,” said Dr. Eyal Ballan, Chief Technology Officer, Cannabics Pharmaceuticals. “Our new and expansive laboratory will enable us to perform our advanced research program in this field.”

Source: Cannabics Pharmaceuticals, Inc.

Last updated: 10/21/14; 10:10am EST