Dronabinol

EQS-News: Acquisition of WEECO Pharma: SYNBIOTIC significantly expands its position in the medical cannabis market

Retrieved on: 
Friday, May 10, 2024
Genetics, Flower, Acquisition, Dronabinol, GMP, Pharmacy, Drug

The German industrial hemp and cannabis group SYNBIOTIC SE acquires WEECO Pharma GmbH from Hildesheim/Germany.

Key Points: 
  • The German industrial hemp and cannabis group SYNBIOTIC SE acquires WEECO Pharma GmbH from Hildesheim/Germany.
  • The merger makes SYNBIOTIC one of the most important players on the German and European market for medicinal cannabis.
  • "This will significantly strengthen our market position in the medical cannabis market."
  • "The acquisition of WEECO Pharma is another key milestone in our successful buy and build strategy," says Daniel Kruse, CEO SYNBIOTIC.

Incannex Healthcare Inc. Quarterly Update, Q1 2024

Retrieved on: 
Tuesday, April 16, 2024
FDA, Psilocybin, Pregabalin, Risk, Obstruction, Phase II, IND, NCT, GAD, Serotonin, Biomarker, Sleep, Deficit spending, Inflammation, Benzodiazepine, Pharmacokinetics, Food, HCQ, IRB, Psychotherapy, Diazepam, Quality of life, OSA, Food and Drug Administration, Pain, Patient, Somnolence, Institutional review board, Safety, Tissue, Bronchitis, PRO, Research, Monash University, Joint, Fatigue, EMA, Dronabinol, PAP, Clinical trial, Asthma, AHI, Accident, COPD, Acetazolamide, NDA, Rheumatoid arthritis, Colitis, Joint stiffness, Obstructive sleep apnea, CBD, Disease, Inflammatory bowel disease, Sleep apnea, Hydroxychloroquine, Cannabidiol, Pharmaceutical industry

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024.

Key Points: 
  • MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024.
  • Incannex is undertaking various U.S. Food and Drug Administration (‘FDA’) research and development (‘R&D’) programs for cannabinoid pharmaceutical products and psychedelic medicine therapies.
  • During the quarter, Incannex released top line results from the PsiGAD1 clinical trial conducted at Monash University, based in Melbourne, Australia.
  • This announcement has been approved for release to NASDAQ by the Incannex Board of Directors.

Incannex Receives IRB Approval for the RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea

Retrieved on: 
Wednesday, January 17, 2024
Ageing, Patient, Research, Dronabinol, PAP, Obstructive sleep apnea, Continuous positive airway pressure, AHI, API, Risk, Positive airway pressure, IRB, Acetazolamide, CPAP, Food, OSA, Safety, Institutional review board, Pharmaceutical industry

IRB approval of the protocol is a key step in activation of clinical trial sites for the RePOSA study.

Key Points: 
  • IRB approval of the protocol is a key step in activation of clinical trial sites for the RePOSA study.
  • The approval process involves review of the research protocol, informed consent procedures, recruitment materials, and participant risk versus benefit analysis.
  • The study is designed to facilitate a seamless transition between Phase 2 and Phase 3, reducing downtime and accelerating development timelines.
  • IRB approval of the protocol allows the U.S.-based sites to proceed with site-specific approval, which is a critical step in site activation.

RespireRx Pharmaceuticals Inc. Announces Agreement with Ponto Ventures to Drive Business Development with Will Clodfelter as RespireRx Part-Time Senior VP of Business Development

Retrieved on: 
Monday, December 11, 2023
Amylin Pharmaceuticals, Biotechnology, Sale, Eli Lilly, Strategic management, OTC Markets Group, Therapy, Business development, RespireRx, Decision Sciences, Dronabinol, Eli Lilly and Company

Mr. Clodfelter will initially lead the business development efforts with respect to dronabinol, the lead asset of ResolutionRx Ltd, a wholly-owned Australian subsidiary of the Company.

Key Points: 
  • Mr. Clodfelter will initially lead the business development efforts with respect to dronabinol, the lead asset of ResolutionRx Ltd, a wholly-owned Australian subsidiary of the Company.
  • Mr. Clodfelter will collaborate with Jeff Eliot Margolis, the Company’s Senior Vice President, Chief Financial Officer, Treasurer and Secretary in driving these efforts.
  • He previously held positions at Eli Lilly and Co. in Corporate Strategy and Business Development.
  • He was at Amylin Pharmaceuticals in New Product Planning and Decision Sciences and was involved in multiple business development activities.

Incannex Update on IHL-42X Drug Candidate in Phase 2/3 Clinical Trial in Obstructive Sleep Apnea

Retrieved on: 
Wednesday, December 6, 2023
Obstructive sleep apnea, Deficit spending, Depression, Disease, Ageing, Blood, Claustrophobia, Accident, Dronabinol, Death, Workplace, Metabolic acidosis, Noise, Conditional sentence, Sleep, Amnesia, Patient, Diagnosis, Cardiovascular disease, PAP, Safety, CO2, AHI, PSG, Somnolence, Acetazolamide, Polysomnography, Judgement, Pharmaceutical industry

Obstructive sleep apnea (OSA) is characterised by a narrowing or obstruction of the upper airway during sleep, which interrupts breathing resulting in decreased oxygen uptake and poor sleep quality.

Key Points: 
  • Obstructive sleep apnea (OSA) is characterised by a narrowing or obstruction of the upper airway during sleep, which interrupts breathing resulting in decreased oxygen uptake and poor sleep quality.
  • Incannex has designed IHL-42X, a combination of dronabinol (synthetic THC) and acetazolamide, for treatment of OSA.
  • A video presentation of IHL-42X for the treatment of OSA has been uploaded to the Incannex website, link here: https://www.incannex.com/clinical-trail/ihl-42x-osa/ .
  • This gave Incannex the confidence to proceed with a multisite Phase 2/3 clinical trial further investigating safety and efficacy of IHL-42X in patients with OSA.

SciSparc Celebrates Major Breakthrough: Positive Results Show its Treatment has a Remarkable Impact on Alzheimer's Agitation

Retrieved on: 
Wednesday, November 15, 2023
Sophie, Hypotension, Cannabinoid, Alzheimer's disease, Eating, IMCA, Delirium, FDA, Agitation, Dronabinol, Tolerability, MD, CMAI, Central nervous system, Pharmaceutical industry, Medical device, Hospital, Disease, Patient, Safety

Tel-Aviv, Nov. 15, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), unveiled positive topline results from its investigator-initiated Phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center (IMCA). The trial results indicated that SciSparc’s proprietary SCI-110 provided a safe and effective solution for alleviating agitation in elderly Alzheimer's patients who participated.

Key Points: 
  • The trial results indicated that SciSparc’s proprietary SCI-110 provided a safe and effective solution for alleviating agitation in elderly Alzheimer's patients who participated.
  • Agitation is a devastating symptom of Alzheimer's Disease (AD), afflicting nearly all patients as the disease progresses, and imposing tremendous suffering and caregiving burdens.
  • The results not only met primary endpoints regarding tolerability and adverse events but also demonstrated SCI-110's potential to alleviate agitation without side effects.
  • Moreover, when measured by the Cohen Mansfield Agitation Inventory (CMAI), our treatment led to a significant 23% reduction in agitation symptoms.

SciSparc Aims to Change Tourette Syndrome Treatments; Will Start a Phase IIb Trial with its Innovative Pharma-Grade THC-Based Medication

Retrieved on: 
Friday, November 10, 2023
Ministry, Safety, TS, Food, Yale University, Disorder, THC, Clinical trial, Medical device, Patient, IIA, FDA, Movement, Hannover Medical School, Cannabinoid, Tourette syndrome, Learning, Central nervous system, Tic, TEL, PEA, Pharmaceutical industry, Dronabinol, Health

TEL AVIV, Israel, Nov. 10, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced the initiation of its Phase IIb clinical trial treating patients suffering from Tourette Syndrome (TS) with its SCI-110, proprietary drug candidate.

Key Points: 
  • SciSparc initiated the trial at the Tel Aviv Sourasky Medical Center in Israel (Sourasky) and is expected to proceed with its U.S. and Germany-based medical sites.
  • TS is a movement and neurobehavioral disorder characterized by motor and vocal tics and is highly linked with co-morbidities.
  • The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo.
  • In addition, the medication was generally well-tolerated by subjects and 12 out of the 16 subjects elected to continue into a 24-week extension phase of the trial.

RespireRx Pharmaceuticals Inc.’s Subsidiary ResolutionRx Ltd Enters into Master Services Agreement for Dronabinol Manufacturing and Related Services

Retrieved on: 
Thursday, October 12, 2023
Master service agreement, Partnership, CSO, MSA, Dronabinol, RespireRx, GMP, OTC Markets Group, Obstructive sleep apnea, Australian Company Number, Pharmaceutical industry

The initial services relate to ResolutionRx’s repurposing of dronabinol and its development program for obstructive sleep apnea pursuant to which Ab Initio will, among other things, manufacture and test our new dronabinol lipid nanoparticle formulation for pharmacokinetic, pharmacodynamic, and pivotal clinical trials, as well as ultimately for commercialization.

Key Points: 
  • The initial services relate to ResolutionRx’s repurposing of dronabinol and its development program for obstructive sleep apnea pursuant to which Ab Initio will, among other things, manufacture and test our new dronabinol lipid nanoparticle formulation for pharmacokinetic, pharmacodynamic, and pivotal clinical trials, as well as ultimately for commercialization.
  • “The importance of this partnership cannot be overstated,” said Arnold Lippa, Ph.D., co-CEO and CSO of ResolutionRx and CEO and CSO of RespireRx.
  • “With its formulation expertise and GMP manufacturing facilities, Ab Initio will complete our original laboratory experiments to determine a final, optimum dronabinol formulation, scale up and manufacture the chosen formulation for clinical use.
  • The lipid nanoparticle technology not only represents a major step forward in the development of dronabinol, but the potential for more widespread use for insoluble or poorly soluble drugs.”

Avextra Signs Distribution Agreements with Pharmaceutical Partners and Commences Exports of Cannabis-based Medicines to Switzerland and Austria

Retrieved on: 
Thursday, September 7, 2023
GMP, Dronabinol, Patient, Cannabis, API, Drug, EU

Avextra has signed distribution agreements with two leading Swiss pharmaceutical partners and one Austrian pharmaceutical distribution partner.

Key Points: 
  • Avextra has signed distribution agreements with two leading Swiss pharmaceutical partners and one Austrian pharmaceutical distribution partner.
  • Under the terms of the agreements, Avextra will supply its purified API Dronabinol as well as standardized cannabis extracts manufactured in its GMP facility in Germany to both Switzerland and Austria.
  • "Switzerland and Austria are important markets for our European expansion given that regulations in both countries continue to expand access for patients and new pharmaceutical distributors begin importing.
  • The latest exports to Switzerland and Austria mark the third and fourth successful exports into EU growth markets for Avextra this year.

Review of IND Application for IHL-42X by US FDA has been completed; Clinical Trial for Patients with Obstructive Sleep Apnoea May Proceed

Retrieved on: 
Tuesday, August 22, 2023
Communication, US Foods, CPAP, Acetazolamide, Sleep, Clinical trial, ASX, Dronabinol, Patient, IRB, AHI, FDA, IND, Food, Safety, Pharmaceutical industry

Incannex submitted the IND application on 20 July 2023 and the FDA completed their review of the substantial application package during the allocated 30-day period.

Key Points: 
  • Incannex submitted the IND application on 20 July 2023 and the FDA completed their review of the substantial application package during the allocated 30-day period.
  • Incannex received communication that the FDA review was completed, and the IND-opening clinical trial is deemed safe to proceed following assessment of the trial protocol, lead trial investigators, and a risk benefit analysis of the trial and prospective product.
  • The IND opening trial will assess the effect of IHL-42X in obstructive sleep apnoea patients who are non-compliant, intolerant, or naïve to positive airway pressure treatment, such as that administered by CPAP devices.
  • In the IND opening Phase 2/3 clinical trial, participants will receive one dose of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the trial.