Corcept has a long way to go to prove to FDA that Corlux, its mifepristone product, works. The early-stage trials were promising, but the first of its three Phase III studies produced disappointing results. Corcept is soldiering on with its two remaining trials, as well as with a separate study, funded by Eli Lilly, involving weight gain. Even if studies of Corlux fail to meet critical endpoints, the tests might still provide clues to improving the current arsenal of treatments for psychosis.
The field of drug development is rife with examples of old drugs being used for new purposes. But Corlux is the exact same drug at the exact same dose as Danco Laboratories' Mifeprex, one of the two pills used to induce a medical abortion. If it successfully completes Phase III trials, the drug could face more than the usual regulatory challenges, and Corcept's management team will need to respond to concerns about access and distribution.They say they're ready. They say that the drug's controversial past is actually an opening for company executives to spotlight what's truly unique and innovative—not just sensational—about their product.
"Most people have never heard of [PMD]," says Fred Kurland, Corcept's chief financial officer. "But most people in this country have heard of the case of Andrea Yates, the woman in Texas who, while suffering from an episode of this disease, unfortunately drowned her five children. It was not only a bad ending for her and her family, but it just displayed yet again the inadequacy that psychiatry has in dealing with this disease."
Psychiatrists often try a combination of antidepressants and antipsychotics to address the disease symptomatically. When those options fail, their next best hope is several treatments with electroconvulsive therapy (ECT), which is administered under general anesthesia and carries significant risk.
Still, while psychosis is the hallmark of the disease, patients experience only a median of three to five episodes over the course of a lifetime. And that profile makes treating PMD akin to treating an infection, Kurland notes.
"PMD is not a chronic disease like, say, schizophrenia; it's an episodic disease," he says. "Now, the episodes are very severe; they last anywhere from six to 18 months. And they are the primary cause of all suicides and homicides that occur. But, interestingly, if you get through an episode...you could be well."