Ethers

Pear Therapeutics Announces Publication of Healthcare Resource Utilization Data Analysis Showing Real-World Cost Impact of reSET-O® in Treating Opioid Use Disorder

Retrieved on: 
Wednesday, July 28, 2021
Technology, Mental health, Mobile, Wireless, Hospitals, Software, Internet, Health, Pharmaceutical, General Health, Opioids, Drugs, Psychoactive drugs, Morphinans, Substance dependence, Tertiary alcohols, Ethers, Phenols, Opioid use disorder, Buprenorphine, Opioid epidemic in the United States, Co-prescribing naloxone with opioids

Pear Therapeutics, Inc. , today announced publication of a new analysis demonstrating the real-world cost impact of reSET-O, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD).

Key Points: 
  • Pear Therapeutics, Inc. , today announced publication of a new analysis demonstrating the real-world cost impact of reSET-O, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD).
  • In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD)14-16.
  • Patients with opioid use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population.
  • Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder.

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
Sleep disorders, Psychoactive drugs, Orphan drugs, Drugs, Stimulants, Chloroarenes, Ethers, Pitolisant, Narcolepsy, Cataplexy, Obstructive sleep apnea, Idiopathic hypersomnia

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.

Sol-Gel Technologies to Report Second Quarter 2021 Financial Results on August 4th, 2021

Retrieved on: 
Tuesday, July 20, 2021
Organic compounds, Chemical compounds, Quinazolines, Tyrosine kinase receptors, Amines, Astellas Pharma, Erlotinib, Ethers, Epidermal growth factor receptor, Chemistry

NESS ZIONA, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (Nasdaq: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, will report second quarter 2021 financial results on Wednesday, August 4, 2021 at 7:05 AM ET.

Key Points: 
  • NESS ZIONA, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (Nasdaq: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, will report second quarter 2021 financial results on Wednesday, August 4, 2021 at 7:05 AM ET.
  • Both product candidates are exclusively licensed forU.S.commercialization withGalderma Holding SA.
  • The Companys pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment ofpalmoplantar keratoderma, and preclinical assets tapinarof and roflumilast.
  • For additional information, please visit www.sol-gel.com .

Athenex Announces European Commission Approval of Klisyri® (tirbanibulin) for the Topical Treatment of Actinic Keratosis

Retrieved on: 
Monday, July 19, 2021
Chemical compounds, Organic compounds, Amides, Ethers, Morpholines, Pyridines, Tirbanibulin, Chemistry, Actinic keratosis, Almirall, AK

This approval by the European Commission marks another significant milestone for Klisyri, shortly following the marketing approval and launch of Klisyri in the U.S., said Dr. Johnson Lau, Chief Executive Officer of Athenex.

Key Points: 
  • This approval by the European Commission marks another significant milestone for Klisyri, shortly following the marketing approval and launch of Klisyri in the U.S., said Dr. Johnson Lau, Chief Executive Officer of Athenex.
  • In December 2020, Athenex received approval from the U.S. Food and Drug Administration (FDA) for the commercialization of Klisyri (tirbanibulin) in the U.S. for the topical treatment of AK of the face or scalp.
  • Our partner Almirall led the U.S. launch of Klisyri in February and is leading the launch of Klisyri in Europe.
  • Klisyri (tirbanibulin) is a microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) of the face or scalp.

Almirall receives European Commission approval of Klisyri® (tirbanibulin), an innovative topical treatment for actinic keratosis

Retrieved on: 
Monday, July 19, 2021
Chemistry, Chemical compounds, Physical sciences, Amides, Ethers, Morpholines, Pyridines, Tirbanibulin, Actinic keratosis, Almirall, Keratosis, AK

BARCELONA, Spain, July 19, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the European Commission (EC) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults.

Key Points: 
  • BARCELONA, Spain, July 19, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the European Commission (EC) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults.
  • "The approval of Klisyrirepresents a breakthrough for actinic keratosis patients, who seek for new treatments that could offer them a better tolerability and short treatment duration.
  • In addition, Almirall has submitted Klisyri for a marketing authorisation in Switzerland in Q4 2020 and the dossier is currently under review by Swissmedic.
  • [4]Chetty P, Choi F, Mitchell T. Primary care review of actinic keratosis and its therapeutic options: a global perspective.

Orexo announces first patient enrolled in pivotal study evaluating the efficacy of modia™ in combination with sublingual buprenorphine/ naloxone for the treatment of OUD

Retrieved on: 
Thursday, July 1, 2021
Opioids, Drugs, Analgesics, Morphinans, Opioid antagonists, Drug rehabilitation, Tertiary alcohols, Ethers, Buprenorphine/naloxone, Buprenorphine, Naloxone, Opioid use disorder

),(STO:ORX) (OTCQX:ORXOY), today announces the enrollment of the first participant in the pivotal study of digital therapeutic modia, in combination with sublingual buprenorphine/naloxone, as part of a clinician-supervised medication-assisted treatment program for the treatment of opioid use disorder (OUD).

Key Points: 
  • ),(STO:ORX) (OTCQX:ORXOY), today announces the enrollment of the first participant in the pivotal study of digital therapeutic modia, in combination with sublingual buprenorphine/naloxone, as part of a clinician-supervised medication-assisted treatment program for the treatment of opioid use disorder (OUD).
  • The randomized, open-label, parallel-group study will evaluate whether the use of modia in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce illicit opioid use.
  • The study is designed to enroll an estimated 400 participants at 35 sites across the US who are voluntarily seeking treatment for documented moderate to severe OUD.
  • The pivotal, randomized, open-label, parallel-group study will evaluate whether the use of modia in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce opioid use.

Orexo announces first patient enrolled in pivotal study evaluating the efficacy of modia™ in combination with sublingual buprenorphine/ naloxone for the treatment of OUD

Retrieved on: 
Thursday, July 1, 2021
Opioids, Drugs, Analgesics, Morphinans, Opioid antagonists, Drug rehabilitation, Tertiary alcohols, Ethers, Buprenorphine/naloxone, Buprenorphine, Naloxone, Opioid use disorder

),(STO:ORX) (OTCQX:ORXOY), today announces the enrollment of the first participant in the pivotal study of digital therapeutic modia, in combination with sublingual buprenorphine/naloxone, as part of a clinician-supervised medication-assisted treatment program for the treatment of opioid use disorder (OUD).

Key Points: 
  • ),(STO:ORX) (OTCQX:ORXOY), today announces the enrollment of the first participant in the pivotal study of digital therapeutic modia, in combination with sublingual buprenorphine/naloxone, as part of a clinician-supervised medication-assisted treatment program for the treatment of opioid use disorder (OUD).
  • The randomized, open-label, parallel-group study will evaluate whether the use of modia in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce illicit opioid use.
  • The study is designed to enroll an estimated 400 participants at 35 sites across the US who are voluntarily seeking treatment for documented moderate to severe OUD.
  • The pivotal, randomized, open-label, parallel-group study will evaluate whether the use of modia in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce opioid use.

George Medicines initiates two Phase III trials of triple combination candidate to treat hypertension

Retrieved on: 
Thursday, July 1, 2021
Organic compounds, Chemical compounds, Chemistry, Chloroarenes, Amines, Amlodipine, Dihydropyridines, Ethers, Indapamide, Angiotensin II receptor blocker, Hypertension, Antihypertensive drug

London, UK, 1 July 2021 George Medicines, a late-stage drug development company focused on providing innovative and accessible medicines for the worlds leading causes of death, today announces the initiation of two Phase III trials investigating its proprietary triple combination candidate, GMRx2, as a first-line treatment for hypertension.

Key Points: 
  • London, UK, 1 July 2021 George Medicines, a late-stage drug development company focused on providing innovative and accessible medicines for the worlds leading causes of death, today announces the initiation of two Phase III trials investigating its proprietary triple combination candidate, GMRx2, as a first-line treatment for hypertension.
  • GMRx2 is a single pill triple combination in novel and proprietary dosage strengths containing telmisartan, amlodipine and indapamide, targeted for first line therapy to control hypertension.
  • Fewer than one in five people with hypertension have the problem under control.3
    The Phase III trials follow successful earlier trials of a low dose triple combination which significantly outperformed traditional high blood pressure treatments without additional side effects.
  • Prof Dr Anthony Rodgers, Chief Scientific Officer of George Medicines, said: We are very pleased to be starting these two Phase III trials.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against AcelRx, Ocugen, and Tarena and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, July 1, 2021
Drugs, Chemical compounds, Anilides, General anesthetics, Janssen Pharmaceutica, Piperidines, Analgesics, Ethers, Sufentanil, Fentanyl

AcelRx is a specialty pharmaceutical company that focuses on the development and commercialization of therapies for the treatment of acute pain.

Key Points: 
  • AcelRx is a specialty pharmaceutical company that focuses on the development and commercialization of therapies for the treatment of acute pain.
  • The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.
  • OnFebruary 16, 2021, AcelRx disclosed that, onFebruary 11, 2021, the Company received a warning letter from the FDA concerning promotional claims for DSUVIA.
  • For more information on the Tarena class action go to: https://bespc.com/cases/TEDU
    About Bragar Eagel & Squire, P.C.

Alkermes Presented New Data Analysis on Healthcare Resource Use Among Veterans With Alcohol Dependence

Retrieved on: 
Wednesday, June 30, 2021
Chemical compounds, United States Department of Veterans Affairs, Alcohols, Healthcare in the United States, Organic compounds, Drinking culture, Substance dependence, Ethers, Naltrexone, Veterans Health Administration, Alcohol dependence, VHA

The company presented results from a retrospective, observational study using data from the Veterans Health Administration (VHA) database, which includes healthcare encounters, treatments and laboratory tests at VHA facilities.

Key Points: 
  • The company presented results from a retrospective, observational study using data from the Veterans Health Administration (VHA) database, which includes healthcare encounters, treatments and laboratory tests at VHA facilities.
  • Details of the poster presentation at RSA are as follows:
    Poster #240: Treatment Patterns and Healthcare Resource Use Among Patients with Alcohol Dependence who Initiated Extended-Release Naltrexone: An Analysis of Veterans Affairs Data, was presented Sunday, June 20.
  • That study was one of the first studies to provide insights into the patient journey among veterans from alcohol dependence diagnosis to VIVITROL initiation and beyond.
  • Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.