Stimulants

RareStone Inc. Announces Submission of New Drug Application (NDA) of Wakix® (pitolisant) for narcolepsy with and without cataplexy in China

Retrieved on: 
Wednesday, July 21, 2021

Wakixwill be considered for approval in the treatment of narcolepsy with and without cataplexy in Greater China.

Key Points: 
  • Wakixwill be considered for approval in the treatment of narcolepsy with and without cataplexy in Greater China.
  • Through a partnership announced in Q4 2020 with Bioprojet, RareStone has exclusive rights for the commercialization and development of Wakixin China.
  • RareStone's lead product candidate, Wakix (pitolisant), is an investigational oral drug in development for the treatment of narcolepsy and obstructive sleep apnea in China.
  • Pitolisant has an orphan designation in the EU and the US for the treatment of narcolepsy.

Corium Launches Innovative ADHD Treatment AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate) in the U.S. for Patients Age 6 Years and Older

Retrieved on: 
Wednesday, July 21, 2021

Corium, a wholly-owned portfolio company of Gurnet Point Capital (GPC), will lead the U.S. commercialization of AZSTARYS.

Key Points: 
  • Corium, a wholly-owned portfolio company of Gurnet Point Capital (GPC), will lead the U.S. commercialization of AZSTARYS.
  • Corium will offer programs to support patients, providers, and health systems through CoriumCaresTM.
  • AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.
  • Do not take AZSTARYS if you or your child are:
    allergic to serdexmethylphenidate, methylphenidate, or any of the ingredients in AZSTARYS.

Global Legal Cocaine Market Report 2021-2025 - Growing Demand for Pharmaceutical-grade Cocaine and Rising Number of Countries Decriminalizing and Legalizing Cocaine - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 21, 2021

The "Global Legal Cocaine Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The publisher has been monitoring the legal cocaine market and it is poised to grow by 2.47 thousand oz during 2021-2025, progressing at a CAGR of almost 4%
    The market is driven by the growing demand for pharmaceutical-grade cocaine and the rising number of countries decriminalizing and legalizing cocaine.
  • The report on the legal cocaine market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors.
  • The report offers an up-to-date analysis regarding the current global market scenario, latest trends and drivers, and the overall market environment.
  • This study identifies the growth in the trade of legal cocaine as one of the prime reasons driving the legal cocaine market growth during the next few years.

Austria Modern Oral Tobacco Products Market report 2021 - ResearchAndMarkets.com

Retrieved on: 
Friday, July 16, 2021

The "Market Report: Modern Oral Products in Austria" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Market Report: Modern Oral Products in Austria" report has been added to ResearchAndMarkets.com's offering.
  • Nicotine pouches are widely available in Austria both online and offline.
  • This report is based on our survey and analysis of both the online and offline modern oral markets.
  • It includes information on availability of modern oral products, top brands, product characteristics such as most available flavour categories and most available nicotine strengths, and pricing information.

Numinus Announces Health Canada Approval of MAPS-Sponsored Open Label Study for MDMA-Assisted Therapy for PTSD

Retrieved on: 
Monday, July 12, 2021

This studyhas advanced through the pre-implementation stage at Numinus' Vancouver clinic and has now received the required federal regulatory approval.

Key Points: 
  • This studyhas advanced through the pre-implementation stage at Numinus' Vancouver clinic and has now received the required federal regulatory approval.
  • During the study, research, medical and therapist staff at Numinus will collectdata on the safety and effectiveness of MDMA-assisted therapyto informHealth Canada andsupport making MDMA-assisted therapy available toindividuals living with PTSD in Canada.
  • "Health Canada should be recognized for its ongoing leadership through its support of this study," said Dr. Christie.
  • These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted therapy.

FDA Approves Supplemental New Drug Application for Adhansia XR® (methylphenidate HCl) Extended-Release Capsules CII

Retrieved on: 
Thursday, July 1, 2021

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the prescribing information for Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII.

Key Points: 
  • Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the prescribing information for Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII.
  • Adhansia XR was approved by FDA for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older in February 2019.
  • Adhansia XR capsules contain identical beads which are formulated using the proprietary smart design MLR (Multi-Layer Release) technology.
  • Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Adhansia XR.

Next Generation Labs Granted European Patent for TFN® Synthetic Nicotine Manufacturing Process Further Strengthening IP Enforcement Efforts Against TFN® Violators

Retrieved on: 
Monday, June 28, 2021

3209653), for its proprietary technology related to the preparation of R-S isomer nicotine.

Key Points: 
  • 3209653), for its proprietary technology related to the preparation of R-S isomer nicotine.
  • "This patent grant by the European Patent Office is a significant milestone for Next Generation Labs, as it solidifies our tobacco-free synthetic nicotine intellectual property portfolio across a number of European countries, allowing the Company to better enforce its rights against violators and counterfeiters of its industry leading TFN branded synthetic nicotine.
  • About Next Generation Labs ('NGL'): Since 2014 NGL has been the world's largest manufacturer of S-isomer, combinational R/S isomer and R-isomer synthetic nicotine under the federally-registered brand name TFN.
  • NGL's TFN products are manufactured under strict conditions to meet cGMP, USP and EU standards to achieve a level of 99.97% pure synthetic nicotine.

Rritual Superfoods Delivers Initial Shipment to Amazon Fulfillment Center

Retrieved on: 
Friday, June 25, 2021

VANCOUVER, BC, June 25, 2021 /PRNewswire/ -Rritual Superfoods Inc. ("Rritual" or the "Company") (CSE: RSF) (FSE: 0RW) (OTC: RRSFF)is pleased to announce the full line of Rritual products have successfully been delivered to the Amazon Fulfillment Center and will be available to customers shortly.

Key Points: 
  • VANCOUVER, BC, June 25, 2021 /PRNewswire/ -Rritual Superfoods Inc. ("Rritual" or the "Company") (CSE: RSF) (FSE: 0RW) (OTC: RRSFF)is pleased to announce the full line of Rritual products have successfully been delivered to the Amazon Fulfillment Center and will be available to customers shortly.
  • We expect Amazon will be an important point of distribution for Rritual."
  • Rritual product offerings are all USDA-certified organic and are a caffeine-free option that can be mixed with other beverages or enjoyed by itself.
  • Rritual markets organic wellness products in the United States through initial retail rollout which includes over 10,000 points of sale and through www.rritual.com .

Praxis Bioresearch Announces Positive Results from Clinical Microdose Study in Humans Showing Oral Activation of Its Novel Prodrug Stimulant PRX-P4-003

Retrieved on: 
Wednesday, June 23, 2021

PRX-P4-003 is a new chemical entity (US Patent 10,662,146) that incorporates an active isomer of fencamfamine [(-)-FCF], a well-tolerated Schedule IV stimulant.

Key Points: 
  • PRX-P4-003 is a new chemical entity (US Patent 10,662,146) that incorporates an active isomer of fencamfamine [(-)-FCF], a well-tolerated Schedule IV stimulant.
  • Prodrug PRX-P4-003 was specifically designed to deliver (-)-FCF selectively by the oral route thus limiting its stimulant activity to oral administration and differentiating it from other FDA approved stimulants.
  • PRX-P4-003 is a new chemical entity prodrug that incorporates an active isomer of fencamfamine [(-)-FCF], a well-tolerated Schedule IV stimulant.
  • The content of this press release is solely the responsibility of Praxis Bioresearch and does not necessarily represent the official views of the NIH.

Government of Canada helping communities address rising methamphetamine use

Retrieved on: 
Thursday, June 17, 2021

The Government of Canada is deeply concerned about this increased use and the risks it poses to the health and safety of people who use methamphetamine, and their communities.

Key Points: 
  • The Government of Canada is deeply concerned about this increased use and the risks it poses to the health and safety of people who use methamphetamine, and their communities.
  • The Government of Canada continues to work with all levels of government, partners, stakeholders, people with lived and living experience and organizations in communities across the country to prevent harms associated with substance use.
  • Together with these organizations, we are helping to provide targeted supports and resources for people using methamphetamine, including those that are specific to Indigenous communities, youth and under-served rural communities."
  • A 2019 study on the impacts of methamphetamine found some Indigenous communities across Canada are increasingly reporting significant health and safety issues related to methamphetamine use.