Drug companies look to profit from DSM-5

June 5, 2013, 8:42 a.m. EDT

Binge eating and hoarding diagnoses may lead to new sales

The changes to the DSM-5, the updated manual of psychiatric illnesses released earlier this month, include 15 new mental disorders. Psychiatrists and consumer advocates hope that the new range of diagnoses will help more people find treatment for their suffering. But drug companies could also see a benefit: It’s likely that the changes will expand the demand for prescription medications that could treat these conditions.

The DSM-5’s changes widen the treatment potential for several mental problems, including depression, premenstrual symptoms, binge eating and dementia. Pharmaceutical experts expect that the DSM-5’s legitimization and expansion of certain disorders will pave the way for companies to develop and sell more drugs to treat them, and increase FDA support for new medications.

For some drugs, a sales impact could come even before the FDA specifically approves them to treat the new DSM-5 disorders. Doctors often prescribe drugs “off-label” to treat disorders, and broader recognition of the disorders could potentially boost sales of the drugs through those channels.

Drug makers aren’t allowed to market medications for their off-label uses—indeed, doing so has resulted in costly fines for companies in the past. For now, most pharmaceutical companies are declining to discuss how the DSM-5 might create new uses for existing drugs. But drugs that could be repurposed and repatented for new psychiatric uses could become important profit sources for their manufacturers, clinicians and physicians say, adding that some of the changes in the DSM-5 could create such opportunities.

Take, for example, the DSM-5’s new guidelines about “bereavement-associated” depression following the loss of a loved one. Previous versions of the DSM recommended against diagnosing major depressive disorder in mourners for eight weeks following a death, but the DSM-5 redacts this “bereavement exclusion.” As a result, says Lisa Cosgrove, a psychologist and professor at the University of Massachusetts in Boston, “what certainly can happen is that, after two weeks, people going through the normal grieving process would then be prescribed an antidepressant.”

Experts say several major brand-name drugs might be used to treat new DSM-5 disorders. Researchers and companies, for example, are eyeing attention deficit disorder drugs like Shire’s Vyvanse to treat binge eating disorder, along with methylphenidate (commonly known as Novartis’s NVS -1.09% Ritalin), as well as some antidepressants, to treat hoarding. Other studies are looking at seizure drugs such as gabapentin, sold by Pfizer as Neurontin, for cannabis withdrawal. “Presumably the drugs have the opportunity to make more money with that new diagnostic,” says Amanda Roberts, associate professor of molecular neurosciences at The Scripps Research Institute, which specializes in the pharmaceutical industry.

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Shire SHPG -1.02% , which recently began its third phase of binge eating trials with Vyvanse, said in its 2012 annual report that the ADHD drug “now holds the prospect of future growth,” thanks in part to its potential for treating binge eating disorder. “We believe there is a significant unmet patient need for a clinically studied and regulatory approved treatment for the condition,” a Shire spokesperson says. Pfizer PFE -0.65% and Novartis say they only endorse their products for the uses indicated on their labels, which do not currently include hoarding or cannabis withdrawal.

Some pharma players are openly positioning themselves to take advantage of additions to the DSM-5. The multiple sclerosis drug Sativex, made by GW Pharmaceuticals, which began trading on the Nasdaq May 8, is being tested for treatment of cannabis withdrawal at the University of New South Wales in Australia, using materials donated by the company, according to a university press release and disclosures by the researchers in a separate 2012 study. GW Pharmaceuticals did not respond to a request for comment. Meanwhile, Lightlake Therapeutics (LLTP), a London-based company that just completed Phase II clinical trials for its nasal spray treatment for binge eating disorder, issued a statement following the release of the DSM-5. “We are very pleased to see that binge eating disorder has been added to the APA’s DSM-5,” Roger Crystal, a surgeon and Lightlake CEO, said in the statement. “Inclusion in DSM-5 should help with reimbursement of therapies for BED.”

Other drugs are likely to get a different kind of boost from the DSM-5—because the manual is recognizing conditions that they’ve already been approved by the FDA to treat. Some Parkinson’s disease medications, for example, are already approved for use for restless legs syndrome, which was added to the psychiatric manual. “I would bet that there are a lot of happy people in the restless-leg pharmaceutical industry right now, because they finally have a real diagnosis,” Roberts says. GlaxoSmithKline’s drug Requip (also available generically) is approved for restless legs syndrome; the company declined to comment on the DSM-5’s potential effect on sales.

Pharmaceutical companies may already be in position to fill the additional prescriptions that will be written thanks to the DSM-5, some say. Now that psychiatrists can officially diagnose depression even when a patient is still grieving a loved one, experts say there may be a market for specialized antidepressants for mourners. Eli Lilly, for one, supported a clinical trial of its antidepressant Cymbalta for treating “bereavement-associated” depression. While the company says it is not currently evaluating Cymbalta for bereavement, Cosgrove notes that Lilly and other pharmaceutical firms have successfully expanded the uses for their drugs in the past. Some antipsychotic drugs, for example, have eventually been approved by the FDA for depression, bipolar disorder and autism. While Cymbalta was originally approved for diabetic peripheral neuropathy, according to the FDA, in recent years it has gained additional approvals for anxiety, depression, fibromyalgia, and most recently, chronic lower back pain—sometimes after relatively few clinical trials.

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