In September 2015, when the U.S. Food and Drug Administration accepted an approval application for a drug combined with an ingestible electronic sensor, the two companies that are developing the product declared it a historic landmark. It was the first time the agency had agreed to review an already-approved drug—Otsuka Pharmaceutical’s Abilify (aripiprazole) to treat mental disorders such as schizophrenia—that had been reformulated into a new tablet containing the sensor. The tiny electronic device, made by Proteus Digital Health, will track whether patients are taking their medication, while also measuring their physiologic responses to it.
Robert McQuade, chief strategic officer at Otsuka Pharmaceutical U.S., says the quest to reformulate Abilify was largely aimed at improving the rate at which patients take the medication. “Adherence is so important in schizophrenia,” McQuade says. So-called depot formulations—long-acting injections—of Abilify and similar drugs have been available for years, but some patients don’t like them. “So we started looking around for other technologies that can drive adherence broadly across serious mental illnesses,” McQuade says.
The partnership between Otsuka and Proteus exemplifies a growing trend in the pharmaceutical industry towards pre-empting potential development problems by changing how drugs are designed and studied. And it’s not just old drugs that are making their way to the drawing board. Now scientists and development teams are designing drugs from the ground up to address issues that previously would not have been dealt with until after the products were already on the market, from adherence to pricing pushback to side-effects.
“More and more we’re seeing drug companies realize that they’re no longer being paid just for providing a product—they’re being paid for achieving an outcome. It starts changing their business models,” says Jeff Elton, head of predictive health intelligence for Accenture. “For a long time they thought if they just understood the biology of the disease they could bring forward a new drug that would be superior to what was available before.” Now, Elton says, companies are thinking about overcoming development challenges and achieving optimal patient outcomes starting from the preclinical phase of drug design.
The reformulated version of Abilify works by communicating with a wearable patch and an associated software package. As soon as the drug reaches the stomach, the sensor inside the tablet sends a signal to the patch, which also records data on patient rest and activity patterns. The patch is equipped to send the data to patients’ cell phones, as well as doctors and caregivers, with their consent.