Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) (Olivier Douliery/Sipa USA/Sipa via AP Images)

Con­gress takes an­oth­er look at re­clas­si­fy­ing psilo­cy­bin and MD­MA

Months af­ter Sens. Cory Book­er (D-NJ) and Rand Paul (R-KY) in­tro­duced a bill that would ex­pand ac­cess to Sched­ule I drugs for ter­mi­nal­ly ill pa­tients, the law­mak­ers are tak­ing an­oth­er stab.

Book­er and Paul on Thurs­day in­tro­duced a new bill called the Break­through Ther­a­pies Act, which would al­low the Drug En­force­ment Ad­min­is­tra­tion to make the nec­es­sary find­ings to re­clas­si­fy break­through ther­a­pies such as MD­MA or psilo­cy­bin as Sched­ule II drugs.

The Con­trolled Sub­stances Act was en­act­ed in 1970, and sep­a­rates sub­stances in­to five sched­ules, with Sched­ule I be­ing the most se­ri­ous. MD­MA and psilo­cy­bin are cur­rent­ly Sched­ule I sub­stances, mean­ing they have “no cur­rent­ly ac­cept­ed med­ical use and a high po­ten­tial for abuse” ac­cord­ing to the CSA’s lan­guage. Sched­ule II drugs are still char­ac­ter­ized as hav­ing a high risk of abuse, though they in­clude med­i­cines such as Oxy­Con­tin and Di­lau­did.

Re­clas­si­fy­ing cer­tain ther­a­pies that con­tain Sched­ule I sub­stances would “help fa­cil­i­tate a phased roll-out of these po­ten­tial­ly life­sav­ing ther­a­pies via FDA-ap­proved Ex­pand­ed Ac­cess pi­lot pro­grams,” the sen­a­tors said, and “re­move bur­den­some fed­er­al reg­u­la­tions that im­pede re­search and de­vel­op­ment.”

The new bill dif­fers from their pre­vi­ous­ly in­tro­duced Right to Try Clar­i­fi­ca­tion Act, which would skirt around the FDA’s ex­pand­ed ac­cess pro­gram and the DEA’s reg­u­la­tions around con­trolled sub­stances, and al­low pa­tients to po­ten­tial­ly ac­cess Sched­ule I drugs more eas­i­ly.

“Re­cent stud­ies sug­gest that some Sched­ule I sub­stances such as MD­MA and psilo­cy­bin could rep­re­sent an enor­mous ad­vance­ment for the treat­ment of se­vere post-trau­mat­ic stress dis­or­der, de­pres­sion and ad­dic­tion,” Book­er said in a news re­lease on Thurs­day. “Un­for­tu­nate­ly, reg­u­la­to­ry red tape and a se­ries of bu­reau­crat­ic hur­dles in­volved in study­ing Sched­ule I sub­stances im­pedes crit­i­cal re­search on these and oth­er promis­ing Sched­ule I com­pounds.”

Psilo­cy­bin, an ac­tive sub­stance in “mag­ic mush­rooms,” is cur­rent­ly un­der de­vel­op­ment by a va­ri­ety of com­pa­nies for con­di­tions such as PTSD and treat­ment-re­sis­tant de­pres­sion. Sim­i­lar­ly, MD­MA has been stud­ied in PTSD and anx­i­ety in ter­mi­nal­ly ill pa­tients.

Book­er and Paul aren’t the first to sug­gest that cer­tain ther­a­pies con­tain­ing Sched­ule I sub­stances should be re­clas­si­fied. Just last month, Seat­tle doc­tor Sunil Ag­gar­w­al took his fight to change psilo­cy­bin’s CSA sta­tus to fed­er­al court. While Ag­gar­w­al had asked the DEA in Feb­ru­ary to re­clas­si­fy psilo­cy­bin as a Sched­ule II sub­stance, the agency re­spond­ed that the FDA “has not ar­tic­u­lat­ed any ac­cept­ed med­ical use” for the drug. On Oct. 20, he pe­ti­tioned the Ninth Cir­cuit Court of Ap­peals to re­view the DEA’s de­ci­sion.

Robert Bar­row

Robert Bar­row, whose com­pa­ny MindMed is de­vel­op­ing a range of ther­a­pies based on psy­che­delics such as LSD and MD­MA, told End­points News on Fri­day that “see­ing a step in the right di­rec­tion in terms of en­abling more stream­lined re­search is re­al­ly ex­cit­ing.” The com­pa­ny is al­so sup­port­ing in­ves­ti­ga­tor-ini­ti­at­ed psilo­cy­bin stud­ies at the Uni­ver­si­ty Hos­pi­tal of Basel in Switzer­land.

“One thing I would want to think about more ful­ly and want to di­gest ful­ly is the ex­act im­pli­ca­tion that it does put a high de­gree of fo­cus on the des­ig­na­tion of a prod­uct as a break­through ther­a­py,” he added. “We see op­por­tu­ni­ties be­yond just break­through ther­a­py-des­ig­nat­ed prod­ucts that could ben­e­fit from stream­lined reg­u­la­to­ry func­tion here in the US.”

A cor­rec­tion has been made to clar­i­fy that MindMed does not have an in-house psilo­cy­bin pro­gram, but is sup­port­ing psilo­cy­bin re­search through a col­lab­o­ra­tion with the Uni­ver­si­ty Hos­pi­tal of Basel in Switzer­land.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

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.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

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.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

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.

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

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).

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

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.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

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.