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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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