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FDA launches new pilot program to crack down on unapproved opioids sold online

Photo by FDA/CDC

The FDA is collaborating with the National Telecommunications and Information Administration (NTIA) to launch a pilot program to reduce the availability of unapproved opioids illegally sold online.

FDA approval for Baudax Bio's non-opioid painkiller Anjeso

Baudax Bio has revealed the FDA approval of its non-opioid painkiller Anjeso (meloxicam injection) as a therapy for the management of moderate to severe pain, either when administered as a monotherapy or when used in combination with analgesics which are not nonsteroidal anti-inflammatory drugs (NSAIDS).

The decision was based on efficacy data from two Phase 3 studies and marks the first availability in the US of a 24-hour, intravenous (IV) COX-2 preferential NSAID.

Top Ten most popular articles on Pharmafile.com this week

The coronavirus is again in the news, with the Indian government considering banning exports of medicine as the epidemic threatens vital pharmaceutical supplies from China. This is not just a regional issue, as Europe and the US are also having their drug production pipeline disrupted by the epidemic. 

In UK news, NICE gives initial ‘no’ to NHS England for kidney cancer drug, while experts have called on the organisation to ban the sale of over the counter codeine. 

Experts call on NICE to recommended a ban on OTC codeine sales

Experts have called for a ban on the sale of over the counter codeine as NICE is set to publish its draft guidance for the management of chronic pain next week.

FDA panel votes against Nektar opioid painkiller

FDA unanimously voted against Nektar Therapeutics opioid pankiller (NKTR-181) for chronic lower back pain, prompting the company to withdraw its application.

It voted 27-0 against the approval over concerns of people abusing the drug. They also felt that there was a lack of data to determine the possible abuse when snorted or injected and its potential for liver toxicity.

Rochester Drug Cooperative ceases opioid sales following criminal charges

The Rochester Drug Cooperative (RDC) has announced it will no longer distribute opioid medications after two of its executives were charged with illegally distributing opioids and conspiring to defraud the FDA.

The RDC said in a statement that: "The ever-increasing expenses associated with the legal and regulatory compliance for this segment of drugs are simply not sustainable. While these specific drugs represent a relatively small percent of total sales, they account for significant legal and compliance."

Pharmacies argue that prescribers bear ultimate responsibility for the opioid crisis

Pharmacy chains have argued in federal court that doctors and healthcare practitioners who write prescriptions bear ultimate responsibility for the improper distribution of opioids to patients, not the chains themselves.

The filings were submitted Monday to the federal judge in Cleveland, who has been overseeing national opioid lawsuits. It asked the judge to rule in their favour and reject the claims bought by Ohio county against them.

FDA fuelled opioid crisis by failing to police pharmaceutical companies, new study shows

The FDA’s Risk Evaluation and Mitigation Strategy (REMS), which began in 2012, failed to successfully police the companies creating opioids like Oxycontin, a new study shows.

On Monday, Jama Internal Medicine published a report based on a review of more than 9,700 pages of FDA documents pertaining to REMS.

Top Ten most popular articles on Pharmafile.com this week

Corruption and bribery feature heavily in the news this week. A recently exposed 1997 email chain shows Dr Richard Sackler, member of the billionaire founding family of Purdue Pharma, knew about the potential abuse of opioids by its clients. In India, a recent report by the Support for Advocacy and Training to Health Initiatives (Sathi) revealed the widespread use of bribes by pharmaceutical companies in India, and how they take advantage of the lax government penalties against such actions.

Seizures of black market diazepam tablets double in the UK in a year

The number of illegal diazepam tablets seized by the UK Border Force has doubled in a year, going from 545,000 in 2017 to 1.3 million in 2018.

Diazepam, also known as Valium, it a class-C drug that is used to treat anxiety, muscle spasms and seizures. The medicine is available on the NHS through prescription. The drug is recommended to be taken for no longer than four weeks. A person caught with the drug without a prescription could face a jail sentence of up to two years.

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