The FDA has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) candidate for the treatment of pediatric schizophrenia.
We note that the FDA grants orphan drug designation to candidates that are being developed to treat rare diseases or conditions affecting less than 200,000 people in the U.S. This status makes the candidate eligible for seven years of marketing exclusivity in the U.S. following approval. This designation also makes Insys eligible for certain financial benefits for developing pharmaceutical CBD.
We note that Insys already has orphan drug status for its CBD program for four other indications – glioma, glioblastoma multiforme, Lennox-Gastaut Syndrome and Dravet Syndrome.
The company plans to submit investigational new drug applications for CBD for Dravet Syndrome and Lennox-Gastaut Syndrome by the end of 2014. It intends to start dosing patients in a phase I study on CBD in early 2015.
The company is testing the possibility of developing CBD for additional indications including adult epilepsy, chemotherapy-induced peripheral neuropathy and addiction in cocaine, amphetamines, and opioids. Insys intends to seek orphan drug status for its CBD in these indications, provided they qualify.
Currently, the company is preparing for the resubmission of its new drug application (NDA) for dronabinol oral solution. Last month, Insys had received a Refusal to File Letter from the FDA for the candidate owing to the inadequacy and incompleteness of the pediatric study plan submitted in its new drug application (NDA) in Aug 2014. With no additional studies necessary, the company expects to re-submit the NDA shortly. Insys is looking to get the candidate approved for the treatment of anorexia associated with weight loss in AIDS patients and chemotherapy-induced nausea and vomiting suffered by cancer patients who respond inadequately to conventional antiemetic treatments.
Additionally, Insys is expected to initiate a number of phase III studies in 2015..
Cannabidiol 101: A Peek Into Cannabinoid Chemistry
The endocannabinoid system (ECS) is a complex signaling network within the human body that uses specialized compounds known as cannabinoids to control various bodily processes by interacting with different receptors and regulatory enzymes.
Cannabidiol (CBD) is often referred to as a “phytocannabinoid.” Phytocannabinoids are plant derivatives that contain a number of diverse chemical compounds that can affect appetite, metabolism, pain sensation, inflammation, thermoregulation, vision, mood, and memory. It’s important to note that phytocannabinoids are any plant-derived product capable of either.
Directly interacting with cannabinoid receptors
Sharing chemical similarities with cannabinoids that allow them to interact with other components of the ECS or both.
CBD is the second most prominent compound found in the Cannabis sativa plant; THC is the first. Proponents claim that, unlike THC, CBD can be legally purchased and used throughout the United States when derived from agricultural hemp.
It is non-psychoactive and is thought by some to have a much broader range of medical applications, including beneficial effects on neurodegeneration, autoimmune disorders, heart, and liver health.
Some enthusiasts believe the existence of cannabinoid receptors in the human body signifies that the cannabis plant was intended for therapeutic and recreational consumption. However, this is simply a “chemical coincidence” whereby plant cannabinoids mimic our own.
There are numerous examples of botanical compounds that have some chemical similarity to other hormones. Some of these compounds are called “phytoestrogens” because although they are found in plants, they can interact with hormone receptors in humans.
Scientists are enthusiastic to explore the potential to modulate physiologic systems in healthy individuals.
CBD’s ability to interact with multiple organ systems, combined with its remarkable safety profile and extremely low toxicity, could signify a bright future for this 5,000-year-old botanical superstar.
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