EMA pulls an opioid from the 1950s used to treat dry cough – Endpoints News

The Eu­ro­pean Med­i­cines Agency said Fri­day that it’s pulling from all Eu­ro­pean mar­kets phol­co­dine-con­tain­ing med­i­cines, which are an opi­oid used in adults and chil­dren for the treat­ment of dry cough and in com­bo with oth­er drugs as a treat­ment for cold and flu.
The de­ci­sion to pull the med­i­cines comes as the EMA points to the re­sults from the re­cent ALPHO study, which show that use of phol­co­dine dur­ing the 12 months pre­ced­ing anes­the­sia is linked to a risk of an ana­phy­lac­tic re­ac­tion re­lat­ed to the neu­ro­mus­cu­lar block­ing agents (NM­BAs) used (with an ad­just­ed OR of 4.2, and a 95% con­fi­dence in­ter­val of 2.5 to 6.9).
“Health­care pro­fes­sion­als should con­sid­er ap­pro­pri­ate treat­ment al­ter­na­tives and ad­vise pa­tients to stop tak­ing phol­co­dine-con­tain­ing med­i­cines,” EMA said.
Com­pa­nies mar­ket­ing phol­codines had to con­duct the ALPHO study fol­low­ing a pre­vi­ous safe­ty re­view from 2011.
“As no ef­fec­tive mea­sures have been iden­ti­fied to min­imise this risk, phol­co­dine med­i­cines are be­ing with­drawn from the EU mar­ket,” EMA added Fri­day, telling pa­tients on phol­codines to con­tact their doc­tors or phar­ma­cists and they will pre­scribe an­oth­er drug.
A 2013 re­view of the ev­i­dence link­ing phol­co­dine ex­po­sure to NM­BA hy­per­sen­si­tiv­i­ty not­ed that when phol­co­dine was with­drawn from the Nor­we­gian mar­ket in March 2007, the coun­try saw a “fall in phol­co­dine and sux­am­etho­ni­um sen­si­ti­za­tion rates and al­so in the in­ci­dence of NM­BA ana­phy­lax­is.” But EMA said those stud­ies did not con­vinc­ing­ly es­tab­lish a causal link be­tween phol­co­dine use and ana­phy­lax­is from NM­BA use.
Used as a cough sup­pres­sant since the 1950s, phol­co­dine-con­tain­ing drugs are au­tho­rized in Bel­gium, Croa­t­ia, France, Ire­land, Lithua­nia, Lux­em­bourg and Slove­nia. Phol­co­dine is of­ten used in com­bo with oth­er drugs, made avail­able as syrups, oral so­lu­tions, and cap­sules un­der var­i­ous trade names and as gener­ics, in­clud­ing Dimetane, Bio­ca­lyp­tol and Bron­ca­lene.
“For pa­tients sched­uled to un­der­go gen­er­al anaes­the­sia with NM­BAs, health­care pro­fes­sion­als should check whether pa­tients have used phol­co­dine-con­tain­ing med­i­cines in the last 12 months and main­tain aware­ness about po­ten­tial pe­ri­anaes­thet­ic ana­phy­lac­tic re­ac­tion re­lat­ed to NM­BAs,” EMA said.

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.
As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.
Unlock this article along with other benefits by subscribing to one of our paid plans.
As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.
Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.
Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.
The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.
Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it’s free.
Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.
That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.
Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.
In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.
Unlock this article along with other benefits by subscribing to one of our paid plans.
German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.
Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.
Bristol Myers Squibb and AbbVie are changing up the inflammatory bowel disease (IBD) market with gastroenterologists, thanks to newer-to-market drugs Zeposia and Skyrizi, respectively. The two drugs have made big gains since 2021 in first-line prescriptions, according to Spherix Global Insights’ latest real world tracking report.
Bristol Myers’ first-in-class S1P Zeposia has landed particularly strong, picking up “a sizeable portion of first line patients” in ulcerative colitis (UC), Spherix’s analysis found.
Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it’s free.
More than two and a half years into the pandemic, Johnson & Johnson wants to remind people that nurses are much more than just caregivers.
In the latest iteration of its campaign, J&J honors nurses as “innovators, lifesavers, and fierce patient advocates.” The program got a refresh from last year, including a new tagline, “Where Would the World Be Without Nurses,” and videos that debuted on social media on Thursday.
It is no secret that drug shortages have been prevalent in 2022. Several major drug products, such as amoxicillin and Adderall, have been in short supply for several months and have led to members of Congress applying pressure on the FDA and HHS to resolve the situation.
Speaking at a webinar hosted by the Alliance for a Stronger FDA, Valerie Jensen, the associate director of the FDA’s Drug Shortage Staff, noted both the rise in quality-related issues and increased demand for some products. She called on companies to report such demand increases, even though they are not currently required to do so.
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
© Endpoints Company 2022
If you’re already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.
We’ll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.
ENDPOINTS NEWS Daily at 11:30 AM ET
EARLY EDITION Daily at 7:15 AM ET
ENDPOINTS PHARMA Daily at 2 PM ET
ENDPOINTS MARKETING RX Tue at 2 PM ET
ENDPOINTS FDA+ Wed at 2 PM ET
ENDPOINTS MANUFACTURING Thu at 2 PM ET
ENDPOINTS WEEKLY Sat at 6 AM ET

source