Second "Cannabis" Pill To Be Available In The US

May 18, 2006 - Rockville, MD, USA

Rockville, MD: The US Food and Drug Administration (FDA) this week re-approved a synthetic cannabinoid analogue for prescription use in the United States. The oral pill, marketed as Cesamet (also known as naboline), is an analogue (a structural derivative) of the cannabinoid THC.

It will be available as a Schedule II controlled substance for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.

Marinol (dronabinol), the only synthetic cannabinoid legally available on the US market, is classified as a Schedule III drug under federal law.

Although Cesamet was initially approved by the FDA in 1985, it was later withdrawn from the market by then-manufacturer Eli Lilly for commercial reasons. The drug has been marketed as an anti-nauseant in Canada and the United Kingdom by Valeant Pharmaceuticals, which purchased the rights to Cesamet in 2004. According to the manufacturer, potential adverse reactions to the drug include ataxia (loss of ability to coordinate muscular movement), euphoria, headache, vertigo, increased heart rate, and concentration difficulties.

Cesamet will be available in 1-milligram tablets, meant to be taken twice daily. Marinol (synthetic THC in sesame oil) is available in 2.5mg, 5mg and/or 10mg dosages.

Though legally available in the US, few patients report positive experiences with Marinol because of its high price tag, delayed onset, and heightened psychoactivity.

Mallinckrodt pharmaceuticals is currently developing a generic version of Marinol for sale in the US market.

For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at (202) 483-5500. Additional information on Marinol and synthetic THC is available in NORML's report:

"Marinol vs Natural Cannabis: Pros, Cons, and Options for Patients," online at: http://norml.org/index.cfm?Group_ID=6635

DL: http://norml.org/index.cfm?Group_ID=6910


Non-Psychoactive Cannabinoid Reduces Incidence Of Diabetes, Study Says

May 18, 2006 - Jerusalem, Israel

Jerusalem, Israel: Administration of the non-psychoactive cannabinoid cannabidiol (CBD) lowers incidence of diabetes in animals and may one day play a role in the prevention of human type 1 diabetes, according to preclinical findings published in the March issue of the journal Autoimmunity.

Researchers at Hadassah University Hospital in Jerusalem reported that injections of 5 mg per day of CBD significantly reduced the prevalence of diabetes in mice from an incidence of 86 percent in non-treated controls to an incidence of only 30 percent. In a separate experiment, investigators reported that control mice all developed diabetes at a median of 17 weeks (range 15-20 weeks) while a majority (60 percent) of CBD-treated mice remained diabetes-free at 26 weeks.

Investigators also reported that CBD significantly lowered plasma levels of the pro-inflammatory cykotines (proteins), INF-gamma and TNF-alpha, and significantly reduced the severity of insulitis (an infiltration of white blood cells resulting in swelling) compared to non-treated controls.

"Our results indicate that CBD can inhibit and delay destructive insulitis and inflammatory ... cykotine production in ... mice resulting in decreased incidence of diabetes," authors concluded.

Preclinical trial data published earlier this year found that CBD prevents diabetic retinopathy in animals. The condition, which is characterized by retinal oxygen deprivation, is the leading cause of blindness in working-age adults.

Cannabinoids have also been demonstrated to alleviate certain types of neuropathic pain associated with diabetes, and to reduce glucose levels in animal models of the disease.

For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at (202) 483-5500. Full text of the study, "Cannabidiol lowers incidence of diabetes in non-obese diabetic mice," appears in the March issue of Autoimmunity.

DL: http://norml.org/index.cfm?Group_ID=6909