New technology that allows for daily medications to instead be taken just once a week or month could transform the lives of people with conditions ranging from schizophrenia to opioid addiction, researchers have said.
The method has also been developed for a new type of contraceptive pill – a capsule, initially tested in pigs, that dissolves in the stomach to release a six-armed structure that delivers synthetic hormones over three weeks before falling apart and exiting the body.
Lyndra, the company that is developing the technology – backed by the Bill and Melinda Gates Foundation – plans to start phase 1 trials in humans towards the end of this year. And the technology is also being applied to a host of other medications, including ivermectin for eradicating malaria.
A once-a-week pill containing risperidone, an antipsychotic used for people with schizophrenia and bipolar disorder, is to go into clinical trials this year, the company said, and is expected to be submitted for approval by the U.S. Food and Drug Administration ( FDA) by the end of next year, with approval hoped for by the end of 2024.
Trish Hurter, the chief executive of Lyndra, said reducing the frequency for certain pills could bring health and economic benefits.
“In schizophrenia specifically, adherence is a huge driver of outcomes,” she said. “When people are not maintained on stable therapy, that’s when they have relapses and hospitalizations.”
Not only does a long-lasting pill reduce the chance of missing a dose, but the technology allows for a steady concentration of a drug to be released over a given period.
“When you take daily pills, your drug levels are like a rollercoaster ride,” said Hurter. At the start of the day, levels of the drug in the body can be very high, potentially triggering side-effects, while by the end of the day they may be too low to work.
And there are other advantages to the new approach. “If you’re a parent trying to help an adult child who’s just been diagnosed with schizophrenia, they do not want to be treated like a kid any more and told every day, ‘take your meds’,” Hurter said. “Having that interaction be less frequent just makes the whole thing more respectful, and better for the patient.”
The company also plans to initiate a phase 1 trial for a once-a-week pill containing levomethadone, a drug used for opioid use disorder. Hurter said the approach could bring huge benefits as at present people requiring the drug must visit a clinic every day for observed dosing.
“It’s really hard for you to actually recover and get your life back on track when you’re visiting a clinic every day,” she said, adding that clinic resources were limited, meaning access could be difficult.
“When you think of the daily pill, it’s highly effective provided you take it as prescribed, but hardly anybody does,” said Hurter.
Lyndra is also developing the approach for rosuvastatin, a type of drug used to reduce the risk of cardiovascular disease, as well as a drug to control diabetes.
But Hurter said the technology may not work for all medications. For the approach to work, a week- or month-long dose needs to be able to fit into the capsule – which is not possible for a drug such as metformin, used to treat type 2 diabetes.
And developing that technology has been far from simple. “Building something that can stay in the stomach and last for a week is challenging from a materials design standpoint, because your stomach does like 500 to 1,000 contractions a day,” Hurter said.
Prof Shôn Lewis, a clinical professor of adult psychiatry at the University of Manchester, said it would be important to study whether the approach has the expected impact given the options already available for people with conditions such as schizophrenia, while a key question remained whether Lyndra’s products would be approved in the UK by the National Institute for Health and Care Excellence.
“I think that the definitive trial going is going to be when we do this in real life, with the warts-and-all stuff of people’s everyday lives, and does this really translate into a practical, clinical benefit?” he said.
However, Lewis said weekly pills could be particularly useful in the initial treatment of people relapsing in the community, allowing health professionals to give a single pill rather than having to arrange daily visits to give risperidone. “That could be a crucial step forward,” he said.
Prof Cynthia Graham, an expert in sexual and reproductive health at the University of Southampton, welcomed the approach, saying while long-acting contraceptives such as hormonal implantsand intrauterine systems were very effective, not all women liked them.
“Missing pills is a massive issue still. And just the idea of taking it every day… ”A once-a-month pill could be a positive step, she said. “I think it would be a big addition, I really do.”