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SCIENCE

  • by NORML June 25, 2018

    Regulators at the US Food and Drug Administration today granted market approval for Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD), for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

    The FDA’s decision was not unexpected, as the proprietary extract formulation — developed by the British biotechnology firm GW Pharmaceuticals — had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. Epidiolex had previously received Fast Track Designation and Orphan Drug Status from the FDA. It is the fourth marijuana-based medicine to receive US FDA approval — joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids.

    Commenting on the agency’s decision, NORML Deputy Director Paul Armentano said: “The FDA’s approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis. However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford.” According to the New York Times, analysts expect Epidiolex to cost $2,500 to $5,000 a month.

    He added: “We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis — a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states.”

    Federal agencies have 90 days to determine the scheduling of Epidiolex. The new drug is anticipated to become available to patients later this fall. In clinical trials, patients administered Epidiolex, on average, obtained a 40 percent reduction in seizure frequency.

    Lennox-Gaustaut syndrome is estimated to account for between one and four percent of all cases of childhood epilepsy. Dravet syndrome is estimated to effect about 1 in 40,000 people.

    Despite today’s approval, the FDA acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” FDA Commissioner Scott Gottlieb further added: “This is the approval of one specific CBD medication for a specific use. … [T]his is not an approval of marijuana or all of its components.”

  • by Paul Armentano, NORML Deputy Director June 5, 2018

    More than two-thirds of chronic pain patients registered to legally access medical cannabis products substitute marijuana for prescription opioids, according to data published in The Journal of Headache and Pain.

    Investigators from the United States and Canada assessed the use of medical cannabis and prescription drugs in a cohort of over 2,000 Canadian patients licensed to access marijuana products. Among those patients with a primary diagnosis of chronic pain, 73 percent reported substituting cannabis in place of opioids. Among those patients diagnosed specifically with headache/migraine, cannabis was frequently reported as a substitute for other medications – including opiates (43 percent), anti-depressants (39 percent), NSAIDS (21 percent), triptans (8 percent), and anti-convulsants (8 percent).

    “Most patients in the pain groups reported replacing prescription medications with medicinal cannabis, the most common of which were opiates/opioids across all patient groups,” authors concluded. “This is notable given the well-described ‘opioid-sparing effect’ of cannabinoids and growing abundance of literature suggesting that cannabis may help in weaning from these medications and perhaps providing a means of combating the opioid epidemic.”

    The study’s findings are consistent with those of numerous others finding that patients in medical cannabis access programs significantly reduce or eventually eliminate their use of opioid analgesics over the long-term.

    Full text of the study, “Patterns of medicinal cannabis use, strain analysis, and substitution effect among patients with migraine, headache, arthritis, and chronic pain in a medicinal cannabis cohort,” appears online here.

  • by Paul Armentano, NORML Deputy Director May 8, 2018

    Medical marijuanaPatients enrolled in New York state’s medical cannabis program reduce their use of opioids and spend less money on prescription medications, according to data published online in the journal Mental Health Clinician.

    Investigators from the GPI Clinical Research in Rochester and the University of Buffalo assessed trends in patients’ medical cannabis and prescription drug use following their enrollment into the state’s marijuana access program.

    On average, subjects’ monthly analgesic prescription costs declined by 32 percent following enrollment, primarily due to a reduction in the use of opioid pills and fentanyl patches. “After three months treatment, medical cannabis improved [subjects’] quality of life, reduced pain and opioid use, and lead to cost savings,” authors concluded.

    The study’s findings are similar to those reported among enrollees in other states medical cannabis programs, including the experiences of patients in Illinois, Michigan, Minnesota, New Mexico, and elsewhere.

    The full text of the study, “Preliminary evaluation of the efficacy, safety, and costs associated with the treatment of chronic pain with medical cannabis,” appears online here. NORML’s fact-sheet highlighting the relevant, peer-reviewed research specific to the relationship between cannabis and opioids is available online here.

  • by Paul Armentano, NORML Deputy Director April 30, 2018

    Marijuana researchThe frequent use of cannabis is not associated with changes in brain structure, according to data published online ahead of print in the journal Addiction.

    An international team of scientists from Australia, the United Kingdom, and the United States assessed the relationship between habitual cannabis exposure and grey matter volumes in seven regions of the brain – including the thalamus, hippocampus, amygdala, and the nucleus accumbens – in two large population-based twin samples.

    Researchers reported, “[N]ormal variation in cannabis use is statistically unrelated to individual differences in brain morphology as measured by subcortical volume.”

    By contrast, the repeated use of nicotine was positively associated with significantly smaller thalamus volumes in middle-aged males.

    Authors concluded: “This is the largest exploratory analysis integrating brain imaging with self-report cannabis and comorbid substance use data. After correcting for multiple testing, there was no effect of cannabis use on the volume at any subcortical region of interest in young adults or middle-aged males. … In the context of expanding medicalization and decriminalization and the concerns surrounding the consequences of increased cannabis availability, our findings suggest that normal variation in cannabis use is statistically unrelated to brain morphology as measured by subcortical volumes in non-clinical samples.”

    The findings are consistent with those of prior brain imaging studies reporting that cannabis exposure appears to have little to no significant adverse impact upon brain morphology — particularly when compared to the dramatic effects associated with the alcohol exposure.

    The study’s findings fail to replicate those of a well-publicized 2014 paper which alleged that even casual marijuana exposure may be linked to brain abnormalities, particularly in the amygdala.

    Last week, a meta-analysis of 69 separate studies reported that cannabis exposure in adolescents and young adults is not associated with any significant, residual detrimental effects on cognitive performance. The results from a pair of recently published longitudinal twin studies similarly report that cannabis use is not independently associated with any residual change in intelligence quotient or executive function.

    An abstract of the study, “Testing associations between cannabis use and subcortical volumes in two large population-based samples,” appears online here.

  • by NORML April 18, 2018

    Cannabis exposure in adolescents and young adults is not associated with any significant long-term detrimental effects on cognitive performance, according to a systematic literature review published today in the journal JAMA Psychiatry.

    Investigators affiliated with the University of Pennsylvania, Perelman School of Medicine and with the Children’s Hospital of Pennsylvania reviewed data from 69 separate studies published between 1973 and 2017 involving 8,727 subjects (2,152 frequent or heavy users and 6,575 controls). Researchers reported no significant long-term deficits in memory, attention, or other aspects of cognitive functioning that could be independently attributed to cannabis use, regardless of subjects age of initiation. These findings are in contrast to similar studies assessing the impact of alcohol use and other controlled substances on cognition, which “have shown medium to large effect sizes.”

    Authors concluded: “Associations between cannabis use and cognitive functioning in cross-sectional studies of adolescents and young adults are small and may be of questionable clinical importance for most individuals. Furthermore, abstinence of longer than 72 hours diminishes cognitive deficits associated with cannabis use. [R]esults indicate that previous studies of cannabis youth may have overstated the magnitude and persistence of cognitive deficits associated with marijuana use.”

    Commenting on the study’s findings, NORML Deputy Director Paul Armentano said: “These conclusions are consistent with those of prior studies – in particular, recent longitudinal twin studies reporting that cannabis use is not independently associated with any residual change in intelligence quotient or executive function. These findings, combined with other recent studies reporting that cannabis exposure appears to have minimal adverse impact on brain morphology — particularly when compared to the dramatic effects of alcohol —dispute the long-standing ‘stoner-stupid’ stereotype. These findings should help to assuage fears that cannabis’ acute effects on behavior may persist long after drug ingestion, or that they may pose greater potential risks to the developing brain.”

    Presently, the medical use and dispensing of cannabis is regulated in 30 states. Eight states also regulate the retail sale of cannabis to adults. According to numerous peer-reviewed studies, neither the enactment of medicalization or adult use legalization has been linked to increased marijuana use or access by young people.

    Full text of the new study, “Association of cannabis with cognitive functioning in adolescents and young adults: A systematic review and meta-analysis,” appears in JAMA Psychiatry.

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