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FDA rejects MDMA for treating PTSD, calls for redo of study, drugmaker says
The Food and Drug Administration declined Friday to approve an application to treat post-traumatic stress disorder using the drug midomafetamine, also known as MDMA or the street drug ecstasy, citing “significant limitations” with the data submitted to the agency.
Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen they argued could be a breakthrough for treating challenging cases of PTSD.
Lykos said the FDA asked for another phase 3 trial to study the safety and efficacy of MDMA.
“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” Amy Emerson, the CEO of Lykos Therapeutics, said in a release.
Emerson said that conducting another phase 3 study, as requested by the FDA, “would take several years” to be done. Phase 3 trials are typically the final and largest stages of clinical studies that drugmakers conduct before seeking approval.
Lykos acknowledged that the concerns the FDA raised echoed those that were brought up by an advisory committee earlier this year. That panel had voted by a majority against the application over a number of concerns about the trials it had done so far.
The company says it plans to eventually seek resubmission, as it works “diligently in the coming months to address” the concerns raised by the agency.
Calls for the FDA to approve the application have mounted in recent weeks ahead of the decision, including from veterans groups and lawmakers.
But earning the FDA’s green light hit a stumbling block at a June advisory meeting to discuss the application. While the FDA is not required to follow the advice of its outside expert panels, it usually does.
“As discussed at the Advisory Committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication,” an FDA spokesperson said in a statement.
The spokesperson said the FDA “generally cannot disclose” the details of why it rejected the application, but said Lykos was free to release the letter it received from the FDA.
“The agency recognizes that there is great need for additional treatment options for mental health conditions such as PTSD. We will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies to address these medical needs,” the spokesperson said.
Why an advisory committee voted against MDMA
Lykos said the FDA’s letter echoed the issues that came up during the June advisory committee meeting. Some of the concerns shared by the panel have long plagued attempts to study MDMA and other hallucinogenic drugs like it.
For example, unlike most studies that compare a drug to a placebo to measure its effectiveness, it is difficult to mask whether participants are actually getting MDMA or a dummy — a dilemma that researchers call “functional unblinding.”
Participants in the trial are often eager for the drug they signed up to study and could be more likely to report a benefit when they know they are getting it, compared to the general population of patients suffering from PTSD.
Concerns about the way that trials of the treatment were run also came up throughout the meeting, especially after a number of speakers during the meeting’s time for public comment raised concerns about misconduct and data meddling during the studies.
FDA officials also acknowledged some limits to their ability to regulate use of MDMA.
The FDA has authority to draw up rules around how the drug is marketed and can require some safety measures for patients, like monitoring for a certain amount of time after they are given MDMA.
But the agency told the panel that their hands were tied when it came to regulating the actual content of the therapy that would be paired with the capsules, which the company has said is key to the success of the treatment.
Even among the FDA panelists who voted against the application in June, many also echoed hope about the potential for MDMA to treat patients with PTSD.
“I think this is a really exciting treatment. I’m really encouraged by the results to date, but I feel that both from an efficacy and a safety standpoint, it is still premature,” Dr. Paul Holtzheimer of the National Center for PTSD said at the meeting, explaining his vote against whether the benefits outweighed the risks for patients with PTSD.
Responding to concerns from the meeting
In the time since the meeting, the drugmaker has insisted it remained confident in the “rigor and thoughtfulness that the FDA will give our application” and rejected “misinformation” about its program.
In responding to the concerns raised from the panel, Lykos said the effect seen in its trials was unlikely to be explained by “functional unblinding” only.
They said “psychotherapy is already a regulated field” with standards and oversight. And about specific concerns about misconduct during the studies, Lykos said they were continuing to cooperate with the FDA amid inspections of its clinical trial sites.
In June, the nonprofit Institute for Clinical and Economic Review also cited “substantial concerns” about bias in how the trials were conducted, like therapists encouraging patients only to report positive benefits and not harms.
The drugmaker later criticized the group for relying on “anonymous reports” without corroborating evidence for casting “unfair doubt on the integrity” of the trials.
Lykos also announced a series of “new initiatives and measures of additional oversight” as it prepared for a potential approval, including a pledge to only make the drug commercially available at “top behavioral health facilities” treating patients under “layers of oversight.”
“Given the novelty of this approach, we are taking steps to help ensure additional oversight for this drug plus therapy modality, if FDA approved, and to help integrate into the real-world healthcare setting,” Emerson had said.
Canada announced Wednesday it won’t block access to the popular video-sharing app TikTok but is ordering the dissolution of its Canadian business after a national security review of the Chinese company behind it.
Industry Minister François-Philippe Champagne said it is meant to address risks related to ByteDance Ltd.’s establishment of TikTok Technology Canada Inc.
“The government is not blocking Canadians’ access to the TikTok application or their ability to create content. The decision to use a social media application or platform is a personal choice,” Champagne said.
Champagne said it is important for Canadians to adopt good cybersecurity practices, including protecting their personal information.
He said the dissolution order was made in accordance with the Investment Canada Act, which allows for the review of foreign investments that may harm Canada’s national security. He said the decision was based on information and evidence collected over the course of the review and on the advice of Canada’s security and intelligence community and other government partners.
A TikTok spokesperson said in a statement that the shutdown of its Canadian offices will mean the loss of hundreds of local jobs.
“We will challenge this order in court,” the spokesperson said. “The TikTok platform will remain available for creators to find an audience, explore new interests and for businesses to thrive.”
TikTok is wildly popular with young people, but its Chinese ownership has raised fears that Beijing could use it to collect data on Western users or push pro-China narratives and misinformation. TikTok is owned by ByteDance, a Chinese company that moved its headquarters to Singapore in 2020.
TikTok faces intensifying scrutiny from Europe and America over security and data privacy. It comes as China and the West are locked in a wider tug of war over technology ranging from spy balloons to computer chips.
Canada previously banned TikTok from all government-issued mobile devices. TikTok has two offices in Canada, one in Toronto and one in Vancouver.
Michael Geist, Canada research chair in internet and e-commerce law at the University of Ottawa, said in a blog post that “banning the company rather than the app may actually make matters worse since the risks associated with the app will remain but the ability to hold the company accountable will be weakened.”
Canada’s move comes a day after the election in the United States of Donald Trump. In June, Trump joined TikTok, a platform he once tried to ban while in the White House. It has about 170 million users in the U.S.
Trump tried to ban TikTok through an executive order that said “the spread in the United States of mobile applications developed and owned” by Chinese companies was a national security threat. The courts blocked the action after TikTok sued.
Both the U.S. FBI and the Federal Communications Commission have warned that ByteDance could share user data such as browsing history, location and biometric identifiers with China’s government. TikTok said it has never done that and would not, if asked.
Trump said earlier this year that he still believes TikTok posed a national security risk, but was opposed to banning it.
U.S. President Joe Biden signed legislation in April that would force ByteDance to sell the app to a U.S. company within a year or face a national ban. It’s not clear whether that law will survive a legal challenge filed by TikTok or that ByteDance would agree to sell.
The Trump administration could be a boon for business for private prison companies in the U.S. if the president-elect delivers on his promise to crack down on illegal immigration.
CoreCivic and Geo Group, the two biggest private prison operators in the U.S., both contract with the U.S. Immigration and Customs Enforcement (ICE) to house detained, undocumented migrants. Their stocks soared Wednesday following Trump’s election win, with investors betting the companies will see increased profits from a tough-on-immigration administration.
CoreCivic, which closed at $13.50 a share on November 5, is trading at $22 a share, while Geo Group, which closed at $15 a share Tuesday, is currently trading at $23.75.
“Obviously, investors believe there is going to be a significant increase in opportunity for both of these firms under the Trump administration,” Noble Capital Markets analyst Joe Gomes told CBS MoneyWatch.
Geo Group executives acknowledged on the company’s third-quarter earnings call Thursday that it expects the incoming administration to enact stricter border security policies and that the company stands “ready to provide additional resources to help ICE meet future needs.”
CoreCivic executives also said they believe the election result will drive demand for its services.
ICE is biggest customer
During Trump’s first term in office, from 2017-2021, immigration detention expanded at record levels, according to an ACLU report. In 2019, ICE detained an average of over 50,000 people each day. At times, that number exceeded 56,000 — about 50% more than peak levels during the Obama administration, according to the report. During his first term in office, Trump expanded the federal government’s use of private prison companies to detain immigrants.
As of January 2020, 81% of people detained in ICE custody across the U.S. were held in facilities owned or managed by private prison corporations, according to the ACLU report.
In his second term, President-elect Trump promises a radical shift in policy at the U.S.-Mexico border from his predecessor. That includes a pledge to oversee the largest deportation operation in American history, which could bring significantly more business to CoreCivic and Geo Group.
For the first nine months of 2024, ICE accounted for 30% of each company’s revenue.
Both Geo Group and CoreCivic said they currently have excess capacity to accommodate a larger population of detainees. CoreCivic executives noted that they’re taking steps to prepare to activate additional capacity to meet ICE’s needs. That could include reconfiguring facilities to accommodate a bigger intake area, they noted.
“There is room for an uptick in occupancy from a capacity standpoint and both companies expect an ask from the Trump administration for more beds. The question is how much, and we just don’t know right now,” Wedbush Securities analyst Brian Violino told CBS MoneyWatch.
Monitoring
Geo Group also provides monitoring services for ICE under its Intensive Supervision Appearance Program (ISAP), a monitoring program using wearable technology that serves as an alternative to detention.
“If there is a finite number of beds and a significant number of people are detained, which Trump is discussing in his plans, there could be an increased usage in this alternative to detention,” Violino said.
Geo Group executives said they have the necessary technology and staffing resources to scale up the contract to more than several million participants, if necessary.
Funding from Congress
The degree to which ICE expands its contracts with the two largest private prison companies depends on how big of an increase in funding Congress authorizes. While Republicans won the Senate majority in Tuesday’s election, it remains to be seen which party will obtain control of the U.S. House of Representatives.
“That’s a big part of the story, and if it’s a Republican sweep, it will be easier for Trump to get funding from Congress to support this operation he’s looking to do,” Violino said.
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