Substituted amphetamines

Cipla receives final approval for generic version of Sunovion Pharmaceuticals, Inc.'s Brovana® (Arformoterol Tartrate Inhalation Solution 15 mcg/ 2mL)

Retrieved on: 
Wednesday, June 23, 2021

Cipla's Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.'s Brovana.

Key Points: 
  • Cipla's Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.'s Brovana.
  • According to IQVIA (IMS Health), Brovana had US sales ofapproximately $438M for the 12-month period ending April 2021.
  • Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets.
  • For more, please visit www.cipla.com , or click on Twitter , Facebook , LinkedIn .

MindMed Announces the Publication of New Data on Personalized MDMA Dosing

Retrieved on: 
Monday, April 5, 2021

This study provides the first scientific data for predicting responses to MDMA and optimizing dosing.

Key Points: 
  • This study provides the first scientific data for predicting responses to MDMA and optimizing dosing.
  • Women and men showed comparable MDMA effects if differences in body weight are considered in the dosing of MDMA.
  • Previous minimal MDMA use, defined as previously using MDMA up to five times, did not influence the MDMA effect.
  • In summary, personalizing MDMA dosing may help optimizethe acute MDMA experience including more positive subjective effects of MDMA and reducing adverse effects of MDMA.

InterVivo Solutions and Mindset Pharma to Jointly Develop Advanced Cooperative Psychedelics Evaluation Platform ("COPE")

Retrieved on: 
Tuesday, March 23, 2021

COPE Expected to Be World's First In Vivo Psychedelic Benchmark Data Set

Key Points: 
  • The psychedelics industry requires a standardized reference data set to identify and develop medicines with enhanced therapeutic benefit and improved safety and pharmacological profiles.
  • The Cooperative Psychedelics Evaluation Platform ("COPE") will be an invaluable tool to guide the development of next-generation psychedelic compounds and improve patentability and value in new molecule drug assets.
  • InterVivo and Mindset intend to make COPE available to InterVivo clients pursuing psychedelics drug development projects, with first data sets to be available by June 12th, 2021.
  • Mindset Pharma will co-sponsor the project and will incorporate the testing technology and data sets into their own lead optimization programs.

Millennium Health Presents Real-Time 2020-21 Data on Drug Use: Pre- and Post-COVID, During Kipu's Two-Day "KipuExpo" Online Event. The Shocking Numbers Reveal an Explosion in Fentanyl and Methamphetamine Use, Foreshadowing Potential Trouble Ahead.

Retrieved on: 
Thursday, March 18, 2021

The information presented was from the latest edition of Millennium Health's Signals ReportTM.

Key Points: 
  • The information presented was from the latest edition of Millennium Health's Signals ReportTM.
  • The fourth wave appears to be stimulants, led primarily by growing methamphetamine use.
  • About KipuHealthKipuHealth is the leading enterprise software provider serving the substance use, mental health, and eating disorder communities with its suite of cloud-based products.
  • To read the latest news on Kipu, please visit https://www.kipu.health/kipu-news/ and connect with us on: Facebook | Twitter | LinkedIn | Read our CEO Blog

Noven Submits New Drug Application for Investigational Dextroamphetamine Transdermal System for ADHD

Retrieved on: 
Monday, February 22, 2021

Noven Pharmaceuticals, Inc., (Noven) a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today confirmed it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its dextroamphetamine transdermal system (ATS).

Key Points: 
  • Noven Pharmaceuticals, Inc., (Noven) a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today confirmed it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its dextroamphetamine transdermal system (ATS).
  • Currently, there is no amphetamine-based transdermal treatment option available for ADHD.
  • The NDA submission is supported by results from a multicenter, laboratory classroom study which evaluated the safety and efficacy of ATS in over 100 pediatric patients with ADHD.
  • Novens mission is to develop and offer pharmaceutical products that meaningfully benefit patients around the world, with a commitment to advancing patient care through transdermal drug delivery.

MindMed Signs Partnership with Swiss Psychedelic Drug Discovery Startup MindShift Compounds AG, Expands Development Pipeline and IP Portfolio with Next-Gen Psychedelic and Empathogenic Compounds

Retrieved on: 
Thursday, February 11, 2021

As part of this partnership, MindMed and MindShift Compounds AG have agreed to develop next-gen psychedelic and empathogenic substances together.

Key Points: 
  • As part of this partnership, MindMed and MindShift Compounds AG have agreed to develop next-gen psychedelic and empathogenic substances together.
  • The first initial compounds have already been synthesized by MindShift Compounds AG and related patent applications were filed by MindMed.
  • MindMed plans to begin first-in-human Phase 1 clinical trials as early as Q1 2022 through its existing clinical trial platform for psychedelic and empathogenic compounds in Switzerland.
  • The related synthesis intellectual property and pharmaceutical technology will be owned outright by MindMed, and MindShift Compounds AG will provide all intellectual property related to the new psychedelic compounds exclusively to MindMed.

Zogenix’s FINTEPLA® (Fenfluramine) Oral Solution Now Available in Germany for the Treatment of Seizures in Dravet Syndrome

Retrieved on: 
Monday, February 1, 2021

Patients with Dravet syndrome experience severe and often prolonged seizures that are highly resistant to existing anti-convulsant medications.

Key Points: 
  • Patients with Dravet syndrome experience severe and often prolonged seizures that are highly resistant to existing anti-convulsant medications.
  • FINTEPLA will be available in Germany starting on 1 February 2021 under a controlled access program requested by the European Medicines Agency.
  • In Germany, physicians will register for an identification number before being able to prescribe FINTEPLA via the following website: www.fenfluramin-wichtige-infos.de/verschreiber .
  • These statements include the potential that fenfluramine oral solution will be an important new treatment option for Dravet syndrome patients and Zogenixs plans to commercialize fenfluramine in Europe.

Options Medical Weight Loss Park Ridge to Host Grand Opening in February

Retrieved on: 
Thursday, January 21, 2021

Options Medical Weight Loss offers 5 different options for customers to achieve their weight loss goals.

Key Points: 
  • Options Medical Weight Loss offers 5 different options for customers to achieve their weight loss goals.
  • That is why we offer one on one weight loss counselors to be with you during your weight loss journey," said Will Barton, President/Co-Founder of Options Medical Weight Loss.
  • Options Medical Weight Loss Center is the premier medical weight loss facility offering services in Chicago, South Loop, Glenview, Naperville, Orland Park, Park Ridge, Gahanna, Dublin, the Valley, Chandler/Gilbert, and St. Petersburg.
  • We also understand that an individual's weight loss journey is not always an easy process, which is why we offer FDA approved appetite suppressants including Phentermine as well as other prescriptions used for weight loss, weekly one-on-one weight loss counseling, Lipotropic fat burners, B12 injections, HCG injections, Options Diet System, Options meals and snacks, Options supplements and more to help assist you during your customized weight loss program.

Vallon Pharmaceuticals Announces Presentation of ADAIR Pharmacokinetics and Pharmacodynamic Data at the Virtual 2021 APSARD Annual Meeting

Retrieved on: 
Tuesday, January 19, 2021

There remains a clear unmet need for products that can treat ADHD effectively while attending to the significant problem of stimulant misuse.

Key Points: 
  • There remains a clear unmet need for products that can treat ADHD effectively while attending to the significant problem of stimulant misuse.
  • The first study enrolled 24 subjects and was designed to compare the PK of d-AMPH from ADAIR 10 mg to IR d-AMPH 10 mg administered orally.
  • The primary PD endpoint demonstrated manipulated intranasal ADAIR had significant reduction in drug liking (p
  • All other PD endpoints reflected abuse-deterrent properties for intranasal ADAIR relative to intranasal d-AMPH (e.g., Take Drug Again, High, Subjective Drug Value).

Tris Pharma to Debut Amphetamine Extended-Release Tablet Efficacy and Safety Data at the 2021 APSARD Annual Meeting

Retrieved on: 
Friday, January 15, 2021

The presentation, "Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of the Amphetamine Extended-Release Tablet in Adults with Attention-Deficit/Hyperactivity Disorder," provides original data about the efficacy and safety of the new tablet formulation.

Key Points: 
  • The presentation, "Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of the Amphetamine Extended-Release Tablet in Adults with Attention-Deficit/Hyperactivity Disorder," provides original data about the efficacy and safety of the new tablet formulation.
  • This presentation will be delivered during the Scientific Poster Session on Friday, January 15, 2021 from 6:007:30 PM EST.
  • This new amphetamine extended-release tablet is an investigational agent and is not currently approved for use in any country.
  • Tris Pharma is a New Jersey-based specialty pharmaceutical company focused on the development and commercialization of innovative medicines that address unmet patient needs.