Relivar (dronabinol buccal) / IntelGenx, Sumitomo Pharma, Tetra Bio-Pharma - LARVOL DELTA

Tetra Bio-Pharma Cancels New Drug Submission to Health Canada (Market Screener) - "Tetra Bio-Pharma Inc...today announced it has cancelled its New Drug Submission (NDS) to Health Canada, without prejudice to a refiling once it has completed a new clinical trial that addresses deficiencies raised by the regulator. The NDS was intended to seek marketing approval in Canada for REDUVO™, a therapy for chemotherapy-induced nausea and vomiting. Health Canada’s review of the NDS raised issues regarding the submitted Phase 1 clinical and analytical data that had been performed more than 15 years ago....The Company assessed the regulatory risk of maintaining its NDS in a revision status. By cancelling the application, the Company will be able to resubmit without prejudice."

Canadian regulatory • Chemotherapy-Induced Nausea and Vomiting • Oncology

Dronabinol oral solution in the management of anorexia and weight loss in AIDS and cancer. (PubMed, Ther Clin Risk Manag) - "However, there is no approved indication in the setting of cancer-related anorexia and weight loss. This review aims at presenting available data on the use of oral dronabinol in the management of anorexia and weight loss in HIV/AIDS and cancer, as well as characterizing and highlighting the pharmacotherapeutic considerations of the newest formulation of dronabinol."

Journal • Review • Biosimilar • Gene Therapies • Genetic Disorders • Oncology

""Synthetic #Cannabis-like Drug (dronabinol) Effective for Sleep Apnea" (only Phase 2 study so far though) https://t.co/XdzNmg20ev via @medscape" (@ChrisRalphRx)

P2 data • Biosimilar • Women's Health

Guanfacine Attenuates Adverse Effects of Dronabinol (THC) on Working Memory in Adolescent-Onset Heavy Cannabis Users: A Pilot Study. (PubMed, J Neuropsychiatry Clin Neurosci) - "THC did not significantly affect performance of a recognition memory task or blood pressure while individuals were maintained on either treatment. Although preliminary, these results suggest that guanfacine warrants further testing as a potential treatment for cannabis-induced cognitive deficits."

Journal • Biosimilar

".@ASCO recommends FDA-approved cannabinoids dronabinol/nabilone for nausea/vomiting.. insufficient evidence to recc medical marijuana" (@ShaalanBeg)

Biosimilar

A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users (clinicaltrials.gov) - P1; N=43; Completed; Sponsor: INSYS Therapeutics Inc; Trial primary completion date: Jul 2014 ->May 2014

Trial primary completion date • Biosimilar • Chronic Kidney Disease

Abuse potential assessment of cannabidiol (CBD) in recreational polydrug users: A randomized, double-blind, controlled trial. (PubMed, Epilepsy Behav) - "Administration of a therapeutic dose of CBD (750 mg) showed significantly low abuse potential in a highly sensitive population of polydrug users. Although high and supratherapeutic doses of CBD (1500 mg and 4500 mg, respectively) had detectable subjective effects compared with placebo; the effects were significantly lower than those observed with alprazolam and dronabinol."

Clinical • Journal • Biosimilar • Brain Cancer • CNS Disorders • Epilepsy • Oncology • Solid Tumor

Dronabinol prescribing at one hospital in a state with legalized recreational cannabis (ASAM 2020) - "We found a trend toward an increase in dronabinol prescriptions at the University of Colorado over time, though it did not reach the level of significance. This analysis signals that inpatient prescribing of dronabinol at one institution in a state with high-potency, legalized cannabis occurs with some frequency and may be increasing. Furthermore, prescribing of dronabinol is highest on small surgical subspecialty services, suggesting that prescribing culture varies widely on the inpatient services."

Clinical

Prescription Synthetic Oral Cannabinoid use Among Older Adults with Chronic Obstructive Pulmonary Disease: A Population-Based Cohort Study. (PubMed, Drugs Aging) - "Although incident off-label oral cannabinoid use was relatively low among all older Ontarian adults, this drug class was used with greater frequency and more often in potentially concerning ways among older adults with COPD. These findings raise possible safety concerns, but further research on the respiratory safety of oral cannabinoids among individuals with COPD is needed."

Clinical • Journal

A Case of a Posterior Fossa Atypical Teratoid Rhabdoid Tumor in an Adult Female (ISPRM 2020) - "Rehabilitation course was complicated by poor appetite, which improved on dronabinol and mirtazapine; significant nausea/emesis, which responded to prochlorperazine; and symptomatic orthostatic hypotension that responded to fludrocortisone and midodrine. Given such limited cases reported in adults, overall prognosis and impact of resection and adjuvant therapy remains unclear.Conclusions : AT/RT is a rare, potentially devastating diagnosis which can produce an array of neurologic and functional deficits. These patients would benefit from early access to a multidisciplinary team including oncology, neurosurgery and rehabilitation medicine to assist with ongoing care."

Clinical

"Does @US_FDA FDA approval of the two primary #cannabinoids in #cannabis (#THC in synthetic dronabinol form and 99% #CBD in Epidiolex) not constitute verification of medicinal value? Does @HHSGov not have a patent on non-psychoactive cannabinoids?" (@VetsCannaCoal)

FDA event

Cannabinoid modulation of opioid analgesia and subjective drug effects in healthy humans. (PubMed, Psychopharmacology (Berl)) - "This study indicates that dronabinol did not enhance the analgesic effects of oxycodone and increased abuse- and impairment-related subjective effects. These data suggest that dronabinol may not be an effective or appropriate opioid adjuvant; it could potentially increase opioid dose requirements, while increasing psychoactive opioid effects."

Clinical • Journal

Delta-9-tetrahydrocannabinol intoxication is associated with increased prefrontal activation as assessed with functional near-infrared spectroscopy: A report of a potential biomarker of intoxication. (PubMed, Neuroimage) - "Fifty-four adult, regular (at least weekly) cannabis users received a single oral dose of synthetic THC (dronabinol; 5-50 mg, dose individually tailored to produce intoxication) and identical placebo on two visits at least one week apart. This study demonstrates that THC intoxication causes increased PFC activity, and fNIRS of the PFC can measure this effect. Increased neural activation in PFC represents a potential biomarker for cannabis intoxication."

Biomarker • Journal

Impact of Cannabinoids on Symptoms of Refractory Gastroparesis: A Single-center Experience. (PubMed, Cureus) - "The 'Gastroparesis Cardinal Symptom Index' (GCSI) and an analog scale rating abdominal pain were applied to prospectively assess the effect of cannabinoids, in the form of dronabinol and medical cannabis, on refractory gastroparesis symptoms. Conclusions Cannabinoids dramatically improve the symptoms of gastroparesis. Furthermore, an improvement in abdominal pain with cannabinoids represents a breakthrough for gastroparesis-associated abdominal pain treatment, for which there are currently no validated therapies."

Clinical • Journal

Adherence to Consolidated Standards of Reporting Trials (CONSORT) Guidelines for Reporting Safety Outcomes in Trials of Medical Cannabis and Cannabis-based Medicines for Chronic Noncancer Pain: A Systematic Review. (PubMed, Clin J Pain) - "Better harms assessment and reporting are needed in chronic pain cannabinoid trials. Improvements may be achieved through: expanded education/knowledge translation, increased research regulation by ethics boards, funding agencies and journals, and greater emphasis on safety assessment and reporting throughout research training."

Clinical • Journal • Review

The effect of orally administered dronabinol on optic nerve head blood flow in healthy subjects- a randomized clinical trial. (PubMed, Clin Pharmacol Ther) - "In addition, dronabinol does not alter the autoregulatory response of ONHBF to an experimental increase in OPP. Further studies are needed to investigate whether this effect can also be observed in glaucoma patients."

Clinical • Journal

"Dr Abrams showing dronabinol was INFERIOR to megesterol in increasing appetite and increasing weight and adding together decreased effectiveness of megesterol #GI20" (@realbowtiedoc)

Cannabis and cannabinoids. (PubMed, Med Lett Drugs Ther) - No abstract available.

Journal • Review

Dronabinol use in France between 2004 and 2017. (PubMed, Rev Neurol (Paris)) - "This first investigation into dronabinol in France underlines the need to further investigate prescription practices and efficacy so as to define conditions of good use and the place of dronabinol in pain management."

Journal

"Alkem Laboratories Ltd acquires assets related to Dronabinol API from AbbVie Inc. #AlkemLaboratories #Asset #Acquisition #Dronabinol #API @abbvie https://t.co/AIyf61lzCr" (@equitybulls)

"And dronabinol and related compounds ;)" (@KentsisResearch)

Treatment of Gilles de la Tourette Syndrome with Cannabis-Based Medicine: Results from a Retrospective Analysis and Online Survey. (PubMed, Cannabis Cannabinoid Res) - "In our sample, patients favored THC-rich cannabis over dronabinol and nabiximols, which might be related to the entourage effect of cannabis. However, several limitations of the study have to be taken into considerations such as the open uncontrolled design and the retrospective data analysis."

Journal • Retrospective data

Improving post-hypoxic myoclonus using cannabidiol. (PubMed, Seizure) - No abstract available.

Journal

Cannabinoids for the Neuropsychiatric Symptoms of Dementia: A Systematic Review and Meta-Analysis. (PubMed, Can J Psychiatry) - "Trials were in North America and Europe and explored tetrahydrocannabinol (n = 3), dronabinol (n = 5), or nabilone (n = 1). There is preliminary evidence for the efficacy and tolerability of cannabinoids as treatments for NPS. Population-based studies are needed to characterize their real-world effectiveness and acceptability."

Journal • Retrospective data • Review

Taste disorders following cancer treatment: report of a case series. (PubMed, Support Care Cancer) - "Persisting dysgeusia in cancer survivors may be assessed by patient report and taste testing. The taste most affected in our patients was umami. Treatment trials with current interventions for dysgeusia appeared effective and should be considered in cancer survivors. Understanding taste and flavor function during and following cancer treatment is important in developing rational prospective preventive and interventional strategies."

Clinical • Journal