Morphinans | Jotup

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

Retrieved on:

Wednesday, August 4, 2021

Drugs, Morphinans, Opioid antagonists, Tertiary alcohols, Medicine, Chemistry, Dizziness, Naloxone

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

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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.

Relmada Therapeutics Announces Top-Line Results of Study Evaluating REL-1017 vs Oxycodone for Abuse Potential

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Tuesday, July 27, 2021

Drugs, Health care, Health sciences, Morphinans, Euphoriants, Drug culture, Oxycodone, Clinical research, Design of experiments, Clinical trial, Medroxyprogesterone acetate

The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.

Key Points:

The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.
The scheduling of a drug depends on the analysis of several parameters (receptor studies, animal studies, human studies, history of abuse).
Oxycodone, the active control, was administered at the dose of 40 mg, a standard dose in HAP studies.
Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Acura Pharmaceuticals and AD Pharma Amend License to LIMITx™ LTX-03

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Monday, July 26, 2021

Acura Pharmaceuticals, Euphoriants, Morphinans, Health care, Pharmaceuticals policy, Ketones, LTX, Acura, Hydromorphone, Pharmaceutical industry in China, Psychoactive drugs, Health

PALATINE, Ill., July 26, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharma, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date) to February 28, 2022.

Key Points:

PALATINE, Ill., July 26, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (Agreement) regarding Acuras LIMITx LTX-03 product candidate with Abuse Deterrent Pharma, LLC (AD Pharma) to extend the FDA Acceptance Date for LTX-03 (NDA Acceptance Date) to February 28, 2022.
Clinical studies with hydromorphone (LTX-04) demonstrated reductions in Cmax of up to 65% when up to 8 tablets were ingested.
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and product candidates intended to mitigate the risk of outcomes associated with product misuse.
LIMITx is useful with products whose side effect risks can be mitigated by limiting exposure to a drug in overdose situations.

Reverse the Silence Campaign Casts a National Spotlight on Overdose Risks Associated with Opioid Use

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Monday, July 26, 2021

Psychoactive drugs, Drugs, Medical emergencies, Clinical medicine, Opioids, Morphine, Substance-related disorders, Morphinans, Opioid epidemic, Opioid overdose, Drug overdose, Heroin

An accidental opioid overdose can happen to anyone taking opioids, across any community.

Key Points:

An accidental opioid overdose can happen to anyone taking opioids, across any community.
We are proud to team up with Dani Schaffer, Darren Waller, and this alliance of national nonprofit organizations to help reverse the silence and lessen the stigma of opioid overdoses, which are often accidental.
For more information about Reverse the Silence and how to help stop overdoses, visit ReverseSilence.org .
These national nonprofit organizations share a commitment to combat drug abuse and to spare other Americans of the opioid epidemic that has devastated so many communities across the country.

Prevent Opioid Abuse Calls on Congress to Pass the Opioid Patients’ Right to Know Act

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Thursday, July 22, 2021

Pointing to the record number of opioid overdoses in the wake of the COVID-19 pandemic, Prevent Opioid Abuse today called on Congress to help put the brakes on further spikes in dependence and addiction throughout the nation by moving expeditiously to pass the Opioid Patients Right to Know Act (H1185).

Key Points:

Pointing to the record number of opioid overdoses in the wake of the COVID-19 pandemic, Prevent Opioid Abuse today called on Congress to help put the brakes on further spikes in dependence and addiction throughout the nation by moving expeditiously to pass the Opioid Patients Right to Know Act (H1185).
The Opioid Patients Right to Know Act would create a grant program to incentivize states to require prescribers to discuss the addictive qualities of the drugs with patients and inform them of alternative treatment options before prescribing them for acute pain.
The Opioid Patients Right to Know Act provides the incentives needed to persuade every state in the nation to adopt this proven prevention measure.
The Opioid Patients Right to Know Act is sponsored by U.S. Representative David Trone (D-MD), along with Reps.

RedHill Biopharma Announces Settlement of Movantik® Patent Litigation with Apotex

Retrieved on:

Thursday, July 22, 2021

Health sciences, Life sciences, Health care, Apotex, AstraZeneca, Morphinans, Opioid antagonists, Generic drug, Naloxegol, Oxford–AstraZeneca COVID-19 vaccine, Pharmaceutical industry

RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.

Key Points:

RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.
Under the terms of the settlement agreement, Apotex may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or earlier under certain circumstances.
The settlement with Apotex does not end RedHill's ongoing litigation against the other one ANDA filer.
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.

Orexo's flagship pharmaceutical pipeline asset OX124 enters pivotal trial

Retrieved on:

Friday, July 16, 2021

Drugs, Psychoactive drugs, Opioids, Euphoriants, Morphinans, Morphine, Medical emergencies, Fentanyl, Naloxone, Heroin, Drug overdose, Opioid epidemic in the United States

),(STO:ORX) (OTCQX:ORXOY) today announces that the company has successfully initiated the pivotal trial (OX124-002) for its lead pharmaceutical pipeline asset, OX124.

Key Points:

),(STO:ORX) (OTCQX:ORXOY) today announces that the company has successfully initiated the pivotal trial (OX124-002) for its lead pharmaceutical pipeline asset, OX124.
OX124 is a powerful naloxone rescue medication, designed to reverse opioid overdoses, including those from highly potent synthetic opioids, such as fentanyl.
[2]
The pivotal trial OX124-002 is a 4-period cross-over, comparative bioavailability study in healthy volunteers, comparing two dose regimens of OX124 to two dose regimens of an injection reference product.
The study is intended to be the primary support for the OX124 New Drug Application in the US.

RedHill Biopharma's Movantik® Added as Unrestricted Preferred Brand To A Major National Commercial Formulary Serving over 30 Million Americans

Retrieved on:

Tuesday, July 13, 2021

Drugs, Clinical medicine, Morphinans, Opioid antagonists, Psychoactive drugs, Daiichi Sankyo, Diols, Naloxegol, Abdominal pain, Opioid withdrawal, Opioid

"This important new listing as an unrestricted preferred brand strengthens Movantik's leadership position and now means that over 30 million more Americans will have access to Movantik.

Key Points:

"This important new listing as an unrestricted preferred brand strengthens Movantik's leadership position and now means that over 30 million more Americans will have access to Movantik.
Almost 9 out of 10 U.S. commercial lives are now covered and we continue to work toward additional formulary coverage for the remaining patients."
Movantik (naloxegol) is contraindicated in:
Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik.

Opiant Pharmaceuticals Announces Appointment of Matthew Ruth as Chief Commercial Officer

Retrieved on:

Monday, July 12, 2021

Psychoactive drugs, Drugs, Opioids, Morphinans, Opioid antagonists, Tertiary alcohols, Morphine, Naloxone, Nalmefene, Heroin, Opioid epidemic in the United States, Co-prescribing naloxone with opioids

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.