Business Wire - Depomed Reports Dose Proportionality of Gabapentin GR at the Endocrine Society’s Annual Meeting
MENLO PARK, Calif. — Depomed, Inc. (Nasdaq:DEPO) announced today that results from two studies of Gabapentin GR support the ability of its improved, extended release formulation to achieve dose-proportional absorption of the pain drug, gabapentin. Gabapentin GR extended release tablets are in development for the treatment of postherpetic neuralgia (PHN), a long lasting pain condition caused by nerve damage during a shingles, or herpes zoster, viral infection. The data were reported at the Endocrine Society’s Annual Meeting taking place in Boston.
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“These are very important pharmacokinetic data given that immediate release gabapentin absorption declines at higher doses, causing patients to take more drug more often, to try to achieve pain relief,” said Bret Berner, Ph.D., vice president, Product Development and chief scientific officer of Depomed. “In contrast, Gabapentin GR achieves improved bioavailability at higher doses with a greater percentage of the administered dose reaching the blood stream where it can work to manage pain. Through the use of our AcuForm drug delivery technology, we have improved the absorption of gabapentin. This improvement supports our development of a once- or twice-daily product with potentially fewer side effects such as dizziness and somnolence as was seen in our Phase II clinical trial.”
Two open-label studies were conducted in 33 healthy male volunteers to observe the phamacokinetics of Gabapentin GR compared to immediate release gabapentin and to investigate the dose-proportionality of Gabapentin GR. All treatments were given following a standardized meal (500-600 calories). In the pharmacokinetic study, 15 subjects received single 600 mg doses of either Gabapentin GR or immediate release gabapentin. At the 600 mg dose, Gabapentin GR extended release tablets showed similar bioavailability to immediate release gabapentin. In the dose proportionality study, 19 subjects received single doses of 600, 1200, 1800 and 2400 mgs of Gabapentin GR. The corresponding amounts of gabapentin absorbed into the blood over 24 hours were 35,698 ng.hr/mL, 63,209 ng.hr/mL, 90,893 ng.hr/mL, and 108,572 ng.hr/mL, demonstrating nearly linear dose-proportionality. These important results showed that at higher doses, Gabapentin GR demonstrates nearly proportional blood plasma levels, which in contrast, has historically been a challenge with immediate release gabapentin.
The company is currently conducting a Phase III clinical trial with Gabapentin GR for the treatment of postherpetic neuralgia.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative AcuForm(TM) drug delivery technology to develop novel oral products and improved, extended release formulations of existing oral drugs. AcuForm-based products are designed to provide once daily administration and reduced side effects, improving patient convenience, compliance and pharmacokinetic profiles. Proquin(R) XR (ciprofloxacin hydrochloride) once daily, extended-release tablets have been approved by the FDA for the treatment of uncomplicated urinary tract infections. In addition, regulatory applications for once daily Glumetza(TM) for the treatment of Type II diabetes have been approved in the U.S. and Canada. The company is conducting a Phase III trial in postherpetic neuralgia with its product candidate, Gabapentin GR(TM). Additional information about Depomed may be found at its web site, www.depomedinc.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to those related to our expectations regarding enrollment in clinical trials, our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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