Med Check: Ulotaront Fails Phase 3, Cytisinicline vs Smoking Cessation, and FDA Warning

In July Sumitomo Pharma and Otsuka Pharmaceutical Co. Ltd. announced that ulotaront did not meet its primary endpoints for adults with schizophrenia.

In the DIAMOND 1 study, 435 adults with schizophrenia who had acute psychotic symptoms (persisting no more than two months at the time of study enrollment) took either 50 mg or 75 mg of ulotaront or placebo daily for six weeks. Positive and Negative Syndrome Scale (PANSS) total scores decreased in all three groups over time. However, the change in PANSS total scores from baseline to week 6 was not superior in the treatment groups compared with the placebo groups.

In the DIAMOND 2 study, 464 patients with schizophrenia and acute psychosis took either 75 mg or 100 mg of ulotaront or placebo daily for six weeks. At week 6 both ulotaront treatment groups showed numerically larger mean reductions in PANSS total score from baseline compared with placebo, but again, the results in the treatment groups were not superior to those in the placebo group.

In a statement, Otsuka president and representative director Makoto Inoue said that Otsuka and Sumitomo “will continue to collaborate to explore the full range of possibilities for ulotaront.”

Cytisinicline may be effective for use in smoking cessation, a phase 3 clinical trial has found. The results were published in JAMA in July. The study was funded by the drug’s developer, Achieve Life Sciences.

In the ORCA-2 trial, 810 adults who smoked cigarettes daily and wanted to quit were randomized into three groups: one group took 3 mg cytisinicline three times a day for 12 weeks (the 12-week cytisinicline group), one group took

3 mg cytisinicline three times a day for six weeks and then placebo three times a day for six weeks (the six-week cytisinicline group), and one group took placebo three times a day for 12 weeks (the placebo group).

In a comparison between the 12-week cytisinicline group and the placebo group, 32.6% of participants who took the drug did not smoke during weeks 9 to 12, compared with 7% in the placebo group. Those who took cytisinicline had 6.3 times the odds of quitting compared with the placebo group. In a comparison between the six-week cytisinicline group and the placebo group, 25.3% of participants who took the drug did not smoke during weeks 3 to 6, compared with 4.4% in the placebo group. Those who took cytisinicline for six weeks had 8 times the odds of quitting compared with the placebo group.

Abnormal dreams and insomnia occurred in less than 10% of each group, and rates of headache and nausea in the cytisinicline groups were similar to those in the placebo group.

In July the Food and Drug Administration (FDA) and the Federal Trade Commission issued warning letters to six companies for illegally selling copycat food products containing delta-8 tetrahydrocannabinol (delta-8 THC). According to a statement issued by the FDA, these products can easily be mistaken for traditional foods like chips, cookies, candy, gummies, or other snack food items.

The warning letters were issued to Delta Munchies, Dr. Smoke LLC (also known as Dr. S LLC), Exclusive Hemp Farms/Oshipt, Nikte’s Wholesale LLC, North Carolina Hemp Exchange LLC, and The Haunted Vapor Room.

“Children are more vulnerable than adults to the effects of THC, with many who have been sickened and even hospitalized after eating ‘edibles’ containing it. That’s why we’re issuing warnings to several companies selling copycat food products containing delta-8 THC, which can be easily mistaken for popular foods that are appealing to children and can make it easy for a young child to ingest in very high doses [of delta-8 THC] without realizing it,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D., in the statement. “The products we are warning against intentionally mimic well-known snack food brands by using similar brand names, logos, or pictures on packaging that consumers, especially children, may confuse with traditional snack foods. We’re also concerned that adults could unintentionally take them or take a higher dose than expected and suffer serious consequences.” ■