FDA ap­proves first non-opi­oid to treat with­draw­al symp­toms in adults

The opi­oid ad­dic­tion mar­ket got a new play­er Wednes­day with the FDA ap­proval of Luce­myra, a pill that helps pa­tients man­age symp­toms of with­draw­al.

The drug, which has been used in the Unit­ed King­dom for more than two decades now, is made by Louisville, KY-based US WorldMeds. The spe­cial­ty phar­ma was not grant­ed ap­proval to treat opi­oid use dis­or­der, but in­stead to treat symp­toms of with­draw­al.

Scott Got­tlieb

For those ad­dict­ed to opi­oids, quit­ting cold turkey can be a har­row­ing ex­pe­ri­ence. In as lit­tle as a few hours, pa­tients may ex­pe­ri­ence stom­ach cramps, mus­cle aches and spasms, a pound­ing heart, nau­sea, vom­it­ing and di­ar­rhea. Oth­er symp­toms in­clude anx­i­ety, ag­i­ta­tion, de­pres­sion and in­som­nia.

The NIH says these symp­toms aren’t di­rect­ly life-threat­en­ing, but they can dri­ve the pa­tient back to opi­oid use — of­ten over­dos­ing af­ter ex­pe­ri­enc­ing with­draw­al.

“We know that the phys­i­cal symp­toms of opi­oid with­draw­al can be one of the biggest bar­ri­ers for pa­tients seek­ing help and ul­ti­mate­ly over­com­ing ad­dic­tion,” said FDA com­mis­sion­er Scott Got­tlieb in a state­ment. “The fear of ex­pe­ri­enc­ing with­draw­al symp­toms of­ten pre­vents those suf­fer­ing from opi­oid ad­dic­tion from seek­ing help. And those who seek as­sis­tance may re­lapse due to con­tin­ued with­draw­al symp­toms.”

Sharon Hertz

Luce­myra (lofex­i­dine hy­drochlo­ride) was orig­i­nal­ly in­tend­ed to be a hy­per­ten­sion drug. It re­duces the re­lease of nor­ep­i­neph­rine, a hor­mone be­lieved to play a key role in trig­ger­ing with­draw­al symp­toms. In two ran­dom­ized, dou­ble-blind, place­bo-con­trolled tri­als, 866 adult pa­tients demon­strat­ed the ben­e­fits and safe­ty of the drug. Com­pared to the place­bo group, pa­tients treat­ed with Luce­myra re­port­ed a low­er sever­i­ty of symp­toms. Plus, pa­tients who got Luce­myra were more like­ly to com­plete the course of treat­ment, which can on­ly last for up to 14 days.

The FDA is re­quir­ing 15 ad­di­tion­al stud­ies to fur­ther as­sess the drug’s safe­ty when used in chil­dren, for longer than 14 days, and in oth­er sit­u­a­tions that were not test­ed in the ear­li­er tri­als.

It will be in­ter­est­ing to see whether a drug like Luce­myra com­petes or is used in tan­dem with drugs like Sublo­cade, the in­jectable ver­sion of In­di­v­ior’s pop­u­lar opi­oid use dis­or­der drug Sub­ox­one. Sublo­cade, a month­ly in­jec­tion of buprenor­phine, con­tains a mild opi­oid to help stymie with­draw­al symp­toms for ad­dicts quit­ting opi­oid use.

Sublo­cade is ap­proved to treat opi­oid abuse dis­or­der, but it al­so con­tains opi­oids itelf. Some pa­tients — or doc­tors — may pre­fer an op­tion like Luce­myra to ease with­draw­al symp­toms, as it the drug does not con­tain opi­oids.

“To­day’s ap­proval rep­re­sents the first FDA-ap­proved non-opi­oid treat­ment for the man­age­ment of opi­oid with­draw­al symp­toms and pro­vides a new op­tion that al­lows providers to work with pa­tients to se­lect the treat­ment best suit­ed to an in­di­vid­ual’s needs,” said Sharon Hertz, di­rec­tor of the Di­vi­sion of Anes­the­sia, Anal­ge­sia and Ad­dic­tion Prod­ucts at the FDA.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Patty Murray (D-WA) (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.