Enlarge (credit: Getty | RJ Sangosti)

After an MDMA therapy for post-traumatic stress disorder dramatically failed to impress Food and Drug Administration advisers earlier this month, researchers are moving forward with another psychedelic—a slow-release oral dose of the hallucinogenic drug ketamine—as a therapy for treatment-resistant depression.

In a mid-stage, randomized, placebo-controlled clinical trial, researchers tested slow-release ketamine pills, taken twice weekly. The trial, sponsored by New Zealand-based Douglas Pharmaceuticals, found ketamine to be safe compared with placebo. At the trial's highest dose, the treatment showed some efficacy against depression in patients who had previously tried an average of nearly five antidepressants without success, according to the results published Monday in Nature Medicine.

But the Phase II trial, which started with 231 participants, indicated that the pool of patients who may benefit from the treatment could be quite limited. The researchers behind the trial chose an unusual "enrichment" design to test the depression treatment. This was intended to thwart the high failure rates generally seen in trials for depression treatments, even in patients without treatment-resistant cases. But even after selecting patients who initially responded to ketamine, 59.5 percent of the enriched participants still dropped out of the trial before its completion, largely due to a lack of efficacy.

Enlarge / Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration on March 18, 2021 in Washington, DC. (credit: Getty | Susan Walsh)

The Food and Drug Administration (FDA) on Thursday announced expanded approval for a gene therapy to treat Duchenne muscular dystrophy (DMD)—despite the fact that it failed a Phase III clinical trial last year and that the approval came over the objections of three of FDA's own expert review teams and two of its directors.

In fact, the decision to expand the approval of the therapy—called Elevidys (delandistrogene moxeparvovec-rokl)—appears to have been decided almost entirely by Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research.

Elevidys initially gained an FDA approval last year, also over objections from staff. The therapy intravenously delivers a transgene that codes for select portions of a protein called dystrophin in healthy muscle cells; the protein is mutated in patients with DMD. Last year's initial approval occurred under an accelerated approval process and was only for use in DMD patients ages 4 and 5 who are able to walk. In the actions Thursday, the FDA granted a traditional approval for the therapy and opened access to DMD patients of all ages, regardless of ambulatory status.

Enlarge (credit: Diamond Shruumz)

Cases of illnesses linked to microdosing candies have more than doubled, with reports of seizures and the need for intubation, mechanical ventilation, and intensive care stays. But, there remains no recall of the products—microdosing chocolates, gummies, and candy cones by Diamond Shruumz—linked to the severe and life-threatening illnesses. In the latest update from the Food and Drug Administration late Tuesday, the agency said that it "has been in contact with the firm about a possible voluntary recall, but these discussions are still ongoing."

In the update, the FDA reported 26 cases across 16 states, up from 12 cases in eight states last week. Of the 26 reported cases, 25 sought medical care and 16 were hospitalized. No deaths have been reported.

Last week, the Centers for Disease Control and Prevention released a health alert about the candies. The agency noted that as of June 11, the people sickened after eating Diamond Shruumz candies presented to health care providers with a host of severe symptoms. Those include: central nervous system depression with sedation, seizures, muscle rigidity, clonus (abnormal reflex responses), tremor, abnormal heart rate (bradycardia or tachycardia), abnormal blood pressure (hypotension or hypertension), gastrointestinal effects (nausea, vomiting, or abdominal pain), skin flushing, diaphoresis (excessive sweating), and metabolic acidosis with increased anion gap (an acid-based disorder linked to poisonings).

Enlarge / Diamond Shruumz's "extremely potent" infused cones in "sprinkles" flavor. (credit: Diamond Shruumz)

More people have reported severe poisonings in an ongoing outbreak marked by people seizing and needing to be intubated after consuming microdose candies made by Diamond Shruumz, the Food and Drug Administration reported Tuesday.

There are now at least 12 reported cases across eight states. All 12 people were ill enough to seek medical care, and 10 needed to be hospitalized. The symptoms reported so far include seizures, central nervous system depression (loss of consciousness, confusion, sleepiness), agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting, the FDA reported.

In Tuesday's update, the FDA also expanded the products linked to the illnesses. In addition to all flavors of Diamond Shruumz's Microdosing Chocolate Bars, the agency's warning now covers all flavors of the brand's Infused Cones and Micro Dose and Macro Dose Gummies.

Enlarge / A Diamond Shruumz chocolate bar, which come in a variety of flavors. (credit: diamondshruumz.com)

Various federal and state health officials are sounding the alarm on Diamond Shruumz-brand Microdosing Chocolate Bars. The candy, said to be infused with mushrooms, has been linked to severe illnesses, including seizures, loss of consciousness, confusion, sleepiness, agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting, according to an outbreak alert released by the Food and Drug Administration on Friday.

So far, eight people across four states have been sickened—four in Arizona, two in Indiana, one in Nevada, and one in Pennsylvania, the FDA reported. Of the eight, six have been hospitalized.

"We are urging the public to use extreme caution due to the very serious effects of these products," Maureen Roland, director of the Banner Poison and Drug Information Center in Phoenix, said in a press release earlier this week.