Syndros (dronabinol oral solution) / Insys Therap - LARVOL DELTA

Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P2 trial • Breast Cancer • Colon Cancer • Colorectal Cancer • Oncology • Pain • Solid Tumor

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: VA Office of Research and Development | Active, not recruiting ➔ Recruiting | N=21 ➔ 320

Enrollment change • Enrollment open • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Oral Dronabinol-HIV (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Yale University | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

Oral Dronabinol-HIV (clinicaltrials.gov) - P1 | N=160 | Not yet recruiting | Sponsor: Yale University

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

Medical Cannabis Received by Patients According to Qualifying Condition in a US State Cannabis Program: Product Choice, Dosing, and Age-Related Trends. (PubMed, Curr Ther Res Clin Exp) - "For commercial products with Food and Drug Administration indications, the median CBD total daily dose was 86.9% lower than the recommended doses for patients with seizures (Epidiolex: Jazz Pharmaceuticals, Palo Alto CA) and median THC total daily dose was 65.3% (Syndros: Benuvia Manufacturing, Round Rock, TX) or 79.3% lower (Marinol: Banner Pharmacaps, Inc., High Point, NC) for cancer patients. (Curr Ther Res Clin Exp. 2023; 84:XXX-XXX)."

Journal • CNS Disorders • Epilepsy • Oncology • Pain

Limited benefit and high financial burden of drugs used to manage cancer-associated anorexia/cachexia syndrome (CACS). (ASCO-QC 2021) - "For a 2-week fill, the least expensive options included generic olanzapine 5 mg tab (once daily) and generic mirtazapine 15 mg tab (once daily), costing $4.50 per fill. Brand-name solutions were costly, ranging from $605.50 (megestrol acetate, Megace ES) to $1,156.30 (dronabinol, Syndros)... We found that the costs of drugs used for CACS are highly variable, ranging from $1000 per fill. Overall there is limited data supporting use of drugs for managing CACS. Thus, our findings can help guide patient-clinician discussions about the risk/benefit ratio of a prescription for managing CACS, while highlighting the importance of seeking less expensive formulations when possible."

Oncology

Limited benefit and high financial burden of drugs used to manage cancer-associated anorexia/cachexia syndrome (CACS). (ASCO-QC 2021) - "For a 2-week fill, the least expensive options included generic olanzapine 5 mg tab (once daily) and generic mirtazapine 15 mg tab (once daily), costing $4.50 per fill. Brand-name solutions were costly, ranging from $605.50 (megestrol acetate, Megace ES) to $1,156.30 (dronabinol, Syndros)... We found that the costs of drugs used for CACS are highly variable, ranging from $1000 per fill. Overall there is limited data supporting use of drugs for managing CACS. Thus, our findings can help guide patient-clinician discussions about the risk/benefit ratio of a prescription for managing CACS, while highlighting the importance of seeking less expensive formulations when possible."

Oncology

Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets (clinicaltrials.gov) - P1; N=14; Completed; Sponsor: University of Arizona; Active, not recruiting ➔ Completed; Trial completion date: Dec 2021 ➔ Apr 2021; Trial primary completion date: Dec 2021 ➔ Oct 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Pain • Solid Tumor

Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets (clinicaltrials.gov) - P1; N=14; Active, not recruiting; Sponsor: University of Arizona; Recruiting ➔ Active, not recruiting; N=20 ➔ 14; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Pain • Solid Tumor

Dronabinol for Post-operative Pain After Lumbar Fusion (clinicaltrials.gov) - P4; N=90; Enrolling by invitation; Sponsor: Jeffrey L Gum MD; Not yet recruiting ➔ Enrolling by invitation; Trial completion date: May 2023 ➔ Sep 2023; Initiation date: May 2020 ➔ Sep 2020; Trial primary completion date: May 2023 ➔ Sep 2023

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Pain

[VIRTUAL] Pharmacy compounding strategies for the buccal administration of cannabinoids (ACS-Fall 2020) - "Both natural and synthetic forms of THC and CBD have been approved for their use as active pharmaceutical ingredients in oral medicinal products for the symptomatic alleviation of chemotherapy-induced nausea and vomiting (Marinol, Syndros), spasticity associated to multiple sclerosis (Sativex/Nabiximols) and refractory pediatric epileptic syndromes (Epidiolex). Since oral administration of cannabinoids presents several pharmacokinetic limitations, such as erraticabsorption, extensive first-pass metabolism and delayed onset, optimizing the delivery of cannabinoids through the oral mucosa could offer a competitive alternative for cannabinoid-based therapeutics. Therefore, novel compounded cannabinoid formulations, which allow for dose- and composition-tailoring, aimed at increasing buccal absorption may represent an extremely useful tool for national health services to dispense cannabis through authorized pharmacies."

Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Epilepsy • Multiple Sclerosis • Pediatrics

Clinical Data for the Use of Cannabis-Based Treatments: A Comprehensive Review of the Literature. (PubMed, Ann Pharmacother) - " As more states authorize medical cannabis use, there is an increasing need for high-quality clinical evidence describing its efficacy and safety. This review is intended to serve as a reference for clinicians, so that the risks and realistic benefits of medical cannabis are better understood."

Clinical data • Journal • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • Autism Spectrum Disorder • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Complement-mediated Rare Disorders • Diabetic Neuropathy • Epilepsy • Gastroenterology • Gene Therapies • Genetic Disorders • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Bowel Disease • Mood Disorders • Multiple Sclerosis • Oncology • Pain • Post-traumatic Stress Disorder

Dronabinol for Post-operative Pain After Lumbar Fusion (clinicaltrials.gov) - P4; N=90; Not yet recruiting; Sponsor: Jeffrey L Gum MD

New P4 trial • CNS Disorders • Pain

Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: University of Arizona; Trial completion date: Sep 2019 ➔ Dec 2020; Trial primary completion date: Sep 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

Insys gets bankruptcy court okay for Subsys sale (PMLive) - "Insys Therapeutics has been given the green light to sell its Subsys opioid product – the focus of racketeering charges that forced the company to file for bankruptcy – to BTcP Pharma...Other assets held by the company include Syndros, a liquid dronabinol product approved for chemotherapy-induced nausea and vomiting in patients who don’t respond to other drugs..."

Sales

Uganda: EU approves Uganda's bid to export marijuana (All Africa) - "Control Union Certifications is the EU mandated body for certification of the medical cannabis. Now that EU has approved our products- the medical marijuana exports and the entire manufacturing chain...to export medical marijuana products made in Uganda to European markets...The marijuana exports from a farm in Kasese District include Cannabinol (CBD) and Tetrahydrocannabinol (THC) with mixture of 2.7mg THC and 2.5mg CBD for Sativex drugs approved in USA, Europe and Canada. Oil Risin contain Dronabinol for making Marinol and syndros capsules and CBD enriched creams for various skin disorders."

Commercial • European regulatory