Under the radar   (May 11, 2009)

There's a new drug for type 2 diabetes, just approved by the FDA. Actually, it's an old drug, that has been approved for many years for other medical conditions, and which just got approval for treating diabetes.

I sort of stumbled across the news of its approval after a colleague sent out an e-mail (which indicated that he too was unaware of it until recently). With all the hullabaloo about several recent FDA reviews of diabetes drugs seeking approval for marketing in the United States, it was truly a surprise to me to find one that snuck through under the radar, without a huge sales push from the manufacturer nor attention from the media. Heck, even the company's website doesn't have a press release that the drug has been approved!

So, what gives? Turns out that a drug that's been on the market for many years, bromocriptine (brand name Cycloset), just got FDA approval for treating blood glucose in type 2 diabetes. There's a discussion about the approval on the Internet at BioWorld that spells out why there's no publicity: the maker, VeroScience LLC and its marketing partner, S2 Therapeutics, "are now looking for a major pharmaceutical company to partner with in the manufacturing and marketing of Cycloset." (S2 Therapeutics is so small that I can't even find a website for them!) So two small companies did the diabetes studies on a medication that's already approved for other indications, and now can sell it -- if they can find factories of sufficient size to manufacture enough product, and can partner with someone with the media muscle to pitch their product in a crowded marketplace.

The approved labeling information for Cycloset is at the FDA website. Cycloset is approved as a once-daily product, to be administered in the morning to be taken within two hours after waking in the morning with food. It is available as a 0.8 mg tablet, and the dose can be slowly increased -- on a weekly basis -- to a maximal recommended dose of 6 tablets (4.8 mg) daily. It was approved to be used alone (monotherapy), and as add-on therapy to existing diabetes drugs.

Side effects observed in clinical trials included nausea, fatigue, dizziness, vomiting, and headache. Postmarketing reports with higher doses of bromocriptine used for other indications include psychotic disorders, hallucinations, and fibrotic complications. And the label reminds physicians that "patients should be advised that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, and diaphoresis. Hypotension and syncope may occur more frequently during initial therapy or with an increase in dose at any time. During early treatment with CYCLOSET, patients should be advised to make slow postural changes and to avoid situations that could predispose to serious injury if syncope was to occur."

Cycloset has a novel mechanism of action, compared to other diabetes drugs: the company thinks that the drug works in the brain "to reset hypothalamic centers regulating postprandial insulin-mediated glucose and lipid metabolism to thereby reduce postprandial hyperglycemia and hyperlipidemia." If this is the case, Cycloset could probably be used in combinations with any of the other presently-available diabetes drugs to get better control than either drug alone, although the company apparently hasn't yet done trials of Cycloset in combination with insulin.

So, under the radar, and not available yet. But it's approved for T2DM, and if the manufacturer does hook up with a big pharma partner, I'd anticipate that we may have plenty of publicity about this old drug that's now a new weapon to treat diabetes.

[Editor's Note: Marketing of Cycloset in the USA began in November, 2010.]