The naloxone hydrochloride nasal spray will be made available over-the-counter, therefore not requiring a prescription, in an effort to reduce deaths from opioid abuse.
Emergent’s application for its Narcan product to be sold OTC for the treatment of opioid overdose has been accepted by the US FDA and provided priority review.
CVS Health and Walgreens announce that they will settle all opioid claims against them by US states, while it is reported that Walmart will do the same.
Ensysce Biosciences has partnered with Quotient Sciences to develop an opioid to prevent abuse and overdose, enabling it to make mid-study changes to the formulation based on emerging data.
The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientific’s Nantheia ATL5, a candidate for treating opioid use disorder.
As part of its efforts to reach a global settlement to resolve opioid claims, Mallinckrodt will file for Chapter 11 bankruptcy for its specialty generics subsidiary.
Johnson & Johnson reaches $20m settlement with two US counties on lawsuits regarding the opioid crisis, exits the upcoming federal trial involving several drug manufacturers.
US FDA follows up the first generic approval of naloxone nasal spray by encouraging companies to apply with generic applications amid the North American opioid crisis.
Purdue reaches agreement to settle opioid litigation it is facing in the US by pursuing bankruptcy and providing a suggested $10bn towards the opioid crisis.
Mallinckrodt announces a settlement agreement on a lawsuit included in the first federal trial over the opioid crisis, shortly after reaching a deal on a previous investigation.
J&J is ordered to pay $572m to the state of Oklahoma, after a court judgement found against the pharmaceutical company for its role in the opioid crisis.
WCG acquires Analgesic Solutions for advisement on protocol design and the development of clinical trials in which pain is an indicator of an underlying condition.
The FDA issued a warning letter to McKesson for violations concerning a possible distribution of illegitimate opioid products while calling for action in securing the supply chain from illegitimate medications, especially opioids.
Purdue announced that it has entered into a partnership deal with Alivio to develop a non-opioid painkiller for the treatment of cystitis and bladder pain syndrome.
President Donald Trump signed the SUPPORT Act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn't the only crisis.
President Donald Trump signed the SUPPORT act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn’t the only crisis.
The US FDA has rejected Mallinckrodt Pharmaceuticals’ investigational candidate, stannsoporfin, intended for the treatment of newborns at risk of jaundice.
Australia’s Therapeutic Goods Administration will reclassify all codeine products to ‘prescription only’ from February 1, in a bid to combat opioid tolerance, dependence and poisoning.
Scientists have developed opioid pain relievers that do not slow or stop breathing – the cause of opiate overdose – they say could reduce the risk of accidental death.
Titan has teamed with Opiant to investigate skin implant technology in the administration of opioid antagonists over extended periods, to combat opioid relapse and overdose in outpatients.
Elite Pharmaceuticals has halted trials of its reformulated opioid painkiller SequestOx (naltrexone and oxycodone hydrochloride) after disappointing bioequivalence data from a study testing the drug in combination with a high fat meal.
Lannett Company, Inc. has announced it will invest $50m into its generic analgesic manufacturing subsidiary Cody Labs, creating 45 new jobs in the Wyoming facility.
Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
Daiichi Sankyo will commercialize an abuse-deterrent formulation of the opioid painkiller morphine sulphate in the US in an agreement with developer Inspirion Delivery Sciences.
Grunenthal has reiterated the benefits of its anti-crush intac tech after licensee Endo withdrew its request to have Opana ER labelled as “abuse deterrent."
The US FDA has ordered new labelling changes for immediate-release (IR) opioids but rejects claims that such products pose the same risks as extended-release (ER) opioids.