Depomed's new Parkinson's drug shows promise

Depomed , a specialty pharmaceutical company, reported positive updates in it's most recent 10Q regarding it's phase 1 clinical trial for the treatment of Parkinson's disease with DM-1992, a novel sustained-release formulation of LevoDopa/Carbidopa.

According to the company's 10Q, Depomed completed the study in early August of 2009. "In the study, DM-1992 extended coverage above Levodopa's efficacous threshold and extended the time to peak Levodopa concentration relative to Sinemet CR, the currently available sustained release Levodopa/Carbidopa formulation. One of Depomed's formulation was able to extend the therapeutic duration to nine hours, compared to Sinemet CR's seven hours. Furthermore, the time to peak blood levels was extended to four hours with Depomed's formulation compared to 2 hours for Sinemet CR. The Phase I trial in DM-1992 was a randomized, open-label crossover study that enrolled 18 patients with stable Parkinson's disease." The clinical results of this trial should be released fairly soon.

Depomed's new drug applies it's patented AcuForm technology to a commonly used Parkinson's drug, Sinemet. Despite being the current gold standard, Sinemet is known for it's debilitating side effects. "Waking up in the morning can be a real drawback for Parkinson's patients on Sinemet or Sinemet CR" said our industry expert. "They wake up and the blood levels of Sinemet have dropped so low that it becomes difficult for patients to even get up and take another pill. On the other hand, just after taking Sinemet, patients experience nausea or hallucinations because the tablet dumps the medicine over a narrow period of time." Sinemet CR is usually dosed three times a day and patients often experience nausea or hallucinations shortly after taking their treatment. Furthermore, as the effects of Sinemet wear-off, patients experience severe dyskinesia, especially late at night or in the early morning, when the blood levels of the drug have dropped significantly. Depomed hopes to capitalize on Sinemet's drawbacks, by improving the efficacy and eliminating some of these horrible side effects.

"This is a serious problem. Most Parkinson's patient dread not being able to move in the mornings when the drug wears off or the nausea that occurs just after taking the drug. The problem is so severe that some patients elect to surgically implant a pump so that they can get continuous delivery of Levodopa/Carbidopa." Our analyst was referring to treatments like Duodopa, a patient-operated portable pump that is currently marketed by Solvay Pharmaceuticals

It seems that Depomed's new drug may change all of that.

Depomed uses a technology that capitalizes the expansile properties of certain polymers. These polymers have long been used in the food industry to "fluff" ice cream and are safe. Upon entering the stomach an AcuForm coated pill expands and is retained in the stomach for up to 8 hours. This helps to deliver a drug like Levadopa/Carbidopa over a longer period of time. In this case, Depomed's technology could decrease the daily dosage of Levadopa/Carbidopa and prevent the narrow peaks and sudden drops in plasma levels that leads to side effects like nausea and morning dyskinesia.

"When a Parkinson's patient takes a pill coated with Depomed's technology, they may not experience the same morning dyskinesia as patient on Sinemet or Sinemet CR. Depomed's drug candidate, DM-1992, seems to be well-differentiated and looks to be an improvement over Sinemet." Although the preliminary data from the 10-Q looks promising, no conclusions can be made until Depomed releases the results of the trial, which should be within the coming weeks.

In July 2008, the Michael J. Fox Foundation awarded Depomed a modest preclinical grant under the foundation’s Therapeutics Development Initiative. This grant helped in the development of DM-1992 under the hypothesis that Levodopa/Carbidopa’s window of absorption in the upper gastrointestinal tract can be optimized using Depomed’s AcuForm technology.

Earlier this month, Merck announced that it had licensed Depomed's AcuForm technology for a combination product with Januvia. Depomed is set to report three phase III trials in October of this year.

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