Tertiary alcohols

Hikma announces US launch of KLOXXADO™ (naloxone HCl) nasal spray 8mg

Retrieved on: 
Wednesday, August 4, 2021

For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them.

Key Points: 
  • For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them.
  • We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world.
  • In two pharmacokinetic studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO, one spray in one nostril.
  • The following adverse reactions were reported in two subjects each: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.

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

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.

Study: Common Drugs Associated with Increased Risk for Cardiac Arrhythmia and Sudden Death in Elderly Patients

Retrieved on: 
Wednesday, July 28, 2021

This means outcome studies including the measure of sudden death based on large clinical data sets are especially important to assess the risk of drug-induced arrhythmia.

Key Points: 
  • This means outcome studies including the measure of sudden death based on large clinical data sets are especially important to assess the risk of drug-induced arrhythmia.
  • Of the short-term drugs, researchers found the antibiotics levofloxacin increased the risk of cardiac arrhythmia or sudden death by 51% compared to the amoxicillin control, while erythromycin had an increased risk of 63%.
  • The anti-nausea drug ondansetron increased the risk of a cardiac adverse event by 205%, while the antifungal fluconazole increased the risk by 123%.
  • Current patients prescribed the antipsychotics showed an increased risk of arrhythmia or sudden death of 118% compared to patients who never received the drug.

Opiant Pharmaceuticals Announces Appointment of Matthew Ruth as Chief Commercial Officer

Retrieved on: 
Monday, July 12, 2021

Mr. Ruth brings significant commercial experience to Opiant, including leading the highly successful launch and commercialization of the first nasal naloxone spray approved by the U.S. Food and Drug Administration (FDA) to treat opioid overdose.

Key Points: 
  • Mr. Ruth brings significant commercial experience to Opiant, including leading the highly successful launch and commercialization of the first nasal naloxone spray approved by the U.S. Food and Drug Administration (FDA) to treat opioid overdose.
  • Mr. Ruth will begin his employment with Opiant effective today and report directly to Dr. Roger Crystal, President and CEO.
  • OPNT003, nasal nalmefene, is in development as a potent, rapid-onset, long-acting opioid antagonist for the treatment of opioid overdose.
  • Opiant Pharmaceuticals, Inc., the company that developed NARCAN Nasal Spray, is building a leadingfranchiseof new medicines to combat addictions and drug overdose.

14 - Alpha Demethylase Inhibitors Pipeline Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 8, 2021

The "14 - Alpha Demethylase Inhibitors - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "14 - Alpha Demethylase Inhibitors - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "14-alpha demethylase inhibitors - Pipeline Insight, 2021" report provides comprehensive insights about 12+ companies and 12+ pipeline drugs in 14-alpha demethylase inhibitors pipeline landscape.
  • This segment of the report provides insights about the different 14-alpha demethylase inhibitors drugs segregated based on following parameters that define the scope of the report, such as:
    There are approx.
  • 14-alpha demethylase inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Dipeptidyl Peptidase 4 Inhibitors Pipeline Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 7, 2021

The "Dipeptidyl Peptidase 4 Inhibitors - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Dipeptidyl Peptidase 4 Inhibitors - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "Dipeptidyl peptidase 4 inhibitors - Pipeline Insight, 2021" report provides comprehensive insights about 8+ companies and 8+ pipeline drugs in Dipeptidyl peptidase 4 inhibitors pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Dipeptidyl peptidase 4 inhibitors R&D.
  • Dipeptidyl peptidase 4 inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Opiant Pharmaceuticals Announces Positive Top-line Results of Confirmatory Pharmacokinetic (PK) Study for OPNT003, Nasal Nalmefene, a Novel Investigational Treatment for Opioid Overdose

Retrieved on: 
Tuesday, July 6, 2021

SANTA MONICA, Calif., July 06, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT) today announced positive top-line results from its confirmatory pharmacokinetic (PK) study for OPNT003, nasal nalmefene, for opioid overdose.

Key Points: 
  • SANTA MONICA, Calif., July 06, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT) today announced positive top-line results from its confirmatory pharmacokinetic (PK) study for OPNT003, nasal nalmefene, for opioid overdose.
  • We are very pleased with the results of this confirmatory PK study.
  • Importantly, the data are consistent with the findings of our initial pilot study, said Roger Crystal, M.D., CEO and President, of Opiant.
  • Opiant Pharmaceuticals, Inc., the company that developed NARCAN Nasal Spray, is building a leadingfranchiseof new medicines to combat addictions and drug overdose.

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

),(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

),(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.

FDA Accepts Filing of Abbreviated New Drug Application and Grants Priority Review for Nalmefene HCI Injection for the Treatment of Known or Suspected Opioid Overdose

Retrieved on: 
Thursday, June 10, 2021

Purdue Pharma L.P. (Purdue) announced that FDA has accepted and granted priority review to the companys Abbreviated New Drug Application for the vial dosage form of nalmefene hydrochloride injection.

Key Points: 
  • Purdue Pharma L.P. (Purdue) announced that FDA has accepted and granted priority review to the companys Abbreviated New Drug Application for the vial dosage form of nalmefene hydrochloride injection.
  • Injectable nalmefene, an opioid antagonist designed to reverse opioid overdose, may be another treatment option to help address the growing and continuing crisis of opioid overdose deaths, including those due to fentanyl and other synthetic opioids.
  • The nalmefene vial and prefilled syringe are generic forms of a previously approved opioid antagonist.
  • The nalmefene autoinjector is being developed for use in the community setting by people without medical training.