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  • 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 May 2, 2018

    A three judge panel for the Ninth Circuit Court of Appeals has denied a petition filed by the Hemp Industries Association challenging the DEA’s authority to establish a new administrative drug code specifically for marijuana extracts. The DEA first announced the proposed rule change in 2011, but did not enact the new policy until January 13, 2017.

    In a decision filed on April 30, the Court rejected petitioners’ arguments – opining the DEA’s classification of marijuana extracts does not conflict with the provisions of either the Agricultural Act of 2014 (aka the ‘Farm Bill) or the Consolidated Appropriations Act, which limits the Justice Department from spending federal dollars to intervene in state-sanctioned activities involving marijuana or industrial hemp. The Court also dismissed petitioners’ argument that the rule substantively amended the federal Controlled Substances Act. Justices opined that such extract products, including those containing primarily CBD, were already classified under federal law as schedule I controlled substances.

    The DEA has long contended that it possesses broad regulatory authority over “all parts of the plant Cannabis sativa L.,” including “the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.” The agency includes among this definition products containing cannabidiol or any other non-THC cannabinoids derived from the marijuana plant. It further states, “[T]he Agricultural Act of 2014 does not permit entities [who are not registered with the DEA] … to produce non-FDA-approved drug products made from cannabis.”

    Over a dozen states have enacted legislation in recent years exempting certain persons who possess extracts high in cannabinoid from criminal prosecution. Legislation to approve the retail sale of CBD extracts to adults in Kansas is awaiting gubernatorial action. Indiana lawmakers approved a similar law in April. Several pieces of legislation seeking to exclude CBD from the federal definition of marijuana are pending in Congress. In 2015, Nora Volkow, the Director of the US National Institute on Drug Abuse, publicly acknowledged that CBD is “a safe drug with no addictive effects.”

    Petitioners say that they intend to appeal the ruling.

    The case is Hemp Industries Association et al., v. US Drug Enforcement Administration et al., (No. 17-70162).

  • by Paul Armentano, NORML Deputy Director June 20, 2017

    oil_bottlesOral CBD administration is associated with reduced blood pressure in healthy volunteers, according to clinical trial data published online in the Journal of Clinical Investigation.

    Investigators from the University of Nottingham in the United Kingdom assessed the effects of a single oral dose of 600 mg of CBD extract versus placebo in nine male subjects.

    Cannabidiol administration reduced resting systolic blood pressure and stroke volume (the amount of blood pumped by the left ventricle of the heart in one contraction). Compared to placebo, CBD intake was associated with reduced BP levels following exercise and in response to stress. Increased heart rate was observed following CBD administration, but no “adverse events” were reported by participants either during or following the study sessions.

    Authors concluded: “Our data show that a single dose of CBD reduces resting blood pressure and the blood pressure response to stress, particularly cold stress, and especially in the post-test periods. This may reflect the anxiolytic and analgesic effects of CBD, as well as any potential direct cardiovascular effects. … Further research is also required to establish whether CBD has any role in the treatment of cardiovascular disorders such as a hypertension.”

    Full text of the study, “A single dose of cannabisiol reduces blood pressure in healthy volunteers in a randomized crossover study,” is online here.

  • by Paul Armentano, NORML Deputy Director May 19, 2014

    Minnesota House and Senate lawmakers, along with Democrat Gov. Mark Dayton, agreed late last week to legislation that seeks to provide access to limited preparations of cannabis to qualified patients.

    The finalized language represents a compromise between dueling House (House File 1818) and Senate bills (Senate File 1641), both of which had passed their respective chambers. On Friday afternoon, House lawmakers approved the compromised bill by a vote of 89 to 40. Members of the Senate voted 46 to 16 for the amended measure, sending it to the Governor’s desk. 

    Under the plan, state regulators intend to license two producers of cannabis and up to eight distribution centers. To be eligible to participate in the state’s program, patients need to possess a physician’s recommendation and be diagnosed with one of eight qualifying conditions (cancer/cachexia, glaucoma, HIV/AIDS, Tourette’s Syndrome, Amyotrophic Lateral Sclerosis, seizures — including those characteristic of epilepsy, severe and persistent muscle spasms — including those characteristic of multiple sclerosis, and/or Crohn’s Disease) and/or a terminal illness, and be registered with the state Department of Health.

    Unlike other state medical cannabis programs, the Minnesota plan does not permit qualified patients to possess or obtain whole-plant cannabis. Instead, the forthcoming law mandates that state-licensed distribution centers provide oils, pills, and/or extracts prepared from the plant. Such products would be subject to laboratory testing for purity and potency. Patients’ health care provider must compile ongoing reports in regards to their patients’ progress.

    Cannabis-based preparations are expected to be available to qualified patients by no later than July 1, 2015. Additional details on the forthcoming program are available here.

  • by Paul Armentano, NORML Deputy Director March 25, 2014

    At a public signing ceremony today, Utah’s Republican Gov. Gary Herbert will approve House Bill 105 — aka “Charlee’s Law.” The law, and others like it, ostensibly allows children with treatment-resistant pediatric epilepsy access to extracts of the marijuana plant high in the cannabinoid cannabidiol (CBD).

    While some media outlets are reporting that the passage of these measures are akin to ‘approving medical marijuana,’ such claims are far from accurate.

    Specifically, Utah’s HB 105 — which takes effect on July 1 — is largely unworkable. As written, the law only exempts from state prosecution those with “intractable epilepsy” who possess a cannabis extract that contains more than 15 percent CBD and no more than 0.3 percent THC. Patients must receive a written recommendation from a Utah board certified neurologist and be registered with the state Department of Health before seeking such extracts, which for the time being may only be procured from outside of the state. The extracts must be produced in a lab that possess a state-license to manufacture such products.

    While this language may appear to allow Utah patients to procure CBD products in neighboring medical cannabis states like Colorado, the likelihood of this scenario is highly doubtful. Colorado’s medical marijuana law only allows those who are state residents and who possess a state-issued patient identification card to legally purchase such products. In other words, Utah parents would have to violate Colorado law to obtain high-CBD extracts (which are likely to only be available from a medical dispensary, not a retail cannabis market). Colorado medical marijuana dispensaries would also be in violation of not just the letter of the law, but also the spirit of the law by providing a product they know is intended to be transported across state lines — a clear violation of the guidelines put forward in the August 2013 Department of Justice memo which call for “preventing the diversion of marijuana from states where it is legal in some form to other states.”

    Utah’s forthcoming law also calls on the state Department of Agriculture “to grow or cultivate industrial hemp for the purpose of
    agricultural or academic research,” ostensibly for the purpose of one-day producing high-CBD cannabis medicines. However, it remains to be seen whether such industrial crops can yield therapeutically effective CBD extracts or whether federal lawmakers would even allow such a state-sponsored research project to move forward.

    In Alabama, members of the House and Senate unanimously approved CBD-specific legislation, Senate Bill 174 aka “Carley’s Laws,” late last week. Republican Gov. Robert Bently has announced his intent to sign the measure into law.

    However, like the Utah law, Alabama’s forthcoming law will also be largely unworkable for those who seek to benefit from it. The measure appropriates $1 million dollars for University of Alabama-sponsored research in CBD extracts. Whether such research will actually take place is another story. Because CBD is, like the cannabis plant itself, classified under federal law as a schedule I controlled substance, multiple federal agencies — including the FDA, DEA, NIDA (US National Institute of Drug Abuse), and PHS (Public Health Service) must all sign off on any clinical investigation of the drug — a process that typically takes several years and often ends with federal regulators rejecting the protocol outright. Yet, under “Carley’s Law,” patients may only legally access CBD under if it is “prescribed” during the course of such a federally approved clinical trial.

    Nevertheless, despite these obvious limitations in implementation, lawmakers in various other states — including Florida, Kentucky, Minnesota, South Carolina, and Wisconsin — are considering passing similar measures. (A similar Georgia measure died when lawmakers adjourned late last week.) While the passage of these measures may pose symbolic victories for legislators, they fail to provide tangible benefits to the constituents that they are intended to serve.

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