Describe the exact mechanism of action of Epidiolex.
According to the Epidiolex FDA Approved Package Insert, (Greenwich Biosciences, Inc.), the precise mechanism(s) by which Epidiolex exerts its anticonvulsant effects in humans are unknown. It does not appear to be through cannabidiol receptors.
Have the results of studies examining the impact of maternal marijuana use identified a unique phenotypic congenital anomaly?
Studies evaluating maternal use of marijuana have not found a unique phenotypic signature of prenatal exposure of marijuana. There does appear to be an increased risk of congenital anomalies, particularly gastroschisis, though.
Changes in fetal growth have been described in some epidemiological studies examining the impact of maternal use of marijuana. Do the long‐term patterns of physical growth appear to be affected?
No, long-term physical growth does not appear to be affected. In contrast, long‐term impacts on psychological health have been noted and include increased rates of depressive symptoms and anxiety as well as delinquency.
According to an August 7, 2020 FDA news release, “The safety profile of Olinvyk is similar to other opioids. As with other opioids, the most common side effects of Olinvyk are nausea, vomiting, dizziness, headache and constipation. Olinvyk should not be given to patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction; or known hypersensitivity to the drug. Prolonged use of opioid analgesics during pregnancy can result in neonatal opioid withdrawal syndrome.” “Olinvyk carries a boxed warning about addiction, abuse and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other central nervous system depressants. Unlike other opioids for intravenous administration, Olinvyk has a maximum recommended daily dose limit of 27 milligrams.” https://www.fda.gov/news-events/press-announcements/fda-approves-new-opioid-intravenous-use-hospitals-other-controlled-clinical-settings
What is oliceridine (Olinvyk)? Is it a new FDA-approved opioid?
According to an August 7, 2020 FDA news release, “the FDA approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate. Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures. It is not indicated for at-home use.” https://www.fda.gov/news-events/press-announcements/fda-approves-new-opioid-intravenous-use-hospitals-other-controlled-clinical-settings
The International Association for the Study of Pain (IASP) has updated the definition of pain. What is their new definition of pain?
After 40+ years, the IASP has revised their definition of pain to reflect advances in our understanding of pain. The revised definition emphasizes that tissue damage is not required. The updated definition of pain is: “An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.” The revised definition also includes 6 notes:
Pain is always a personal experience that is influenced to varying degrees by biological, psychological, and social factors
Pain and nociception are different phenomena, and pain cannot be inferred solely from activity in sensory neurons
Through life experiences, people learn the concept of pain
A person’s report of an experience as pain should be respected
Although pain usually serves an adaptive role, it may have adverse effects on function and social and psychological well-being
Verbal description is only one of several behaviors to express pain, and an inability to communicate does not negate the possibility that a human or a nonhuman animal experiences pain
Epidiolex has been approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). Has the FDA approved Epidiolex for any other conditions?
Yes. On July 31, 2020, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.
Does the use of cannabinoid-based products impact female sexual function?
According to a study published in the journal Sexual Medicine, an increased frequency of marijuana use is associated with improved sexual function among females. Interestingly, it was noted that chemovar type and method of consumption did not impact outcomes, though.
CBD and medical marijuana are legal in Florida and California. Do the major amusement parks in these states and other legal marijuana states allow medical marijuana patients to carry CBD and medical marijuana into the amusement parks?
With a few exceptions, the answer is no. Medical marijuana and CBD products are not allowed in Disney parks and resorts (including hotels, shopping and restaurants). Six Flags, Universal, and Cedar Fair also prohibit all forms of legal cannabinoid products, including CBD. In contrast, Sea World properties (which include all Busch Gardens and Sea World parks) allow visitors to carry CBD—but no forms of medical marijuana with significant amounts of THC.
According to an estimate by the United Nations, what percentage of the world’s population used cannabis products in 2016?
The UN estimated that in 2016, 3.9% of the world’s population used cannabis products. (3.9% of the world population is equivalent to ~ 192.2million people)—The UN’s data suggest that there was an increase of 16% compared with estimates of the previous decade.