Gabapentin :: Multiple pharmacies comparison.

M2 Presswire - Depomed Begins Dosing Patients in Phase 2 Trial For Gabapentin GR to Treat Menopausal Hot Flashes.

admin — Sun, 04 Jan 2009 18:27:44 +0000

M2 PRESSWIRE-14 June 2007-ExplorationInvestor: Depomed Begins Dosing Patients in Phase 2 Trial For Gabapentin GR to Treat Menopausal Hot Flashes(C)1994-2007 M2 COMMUNICATIONS LTD RDATE:14062007 Exploration Investor strives to provide you with outstanding market results. We will be your number one resource for all your small and large cap needs.

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While working to keep you in touch with market activity, we also will keep you updated on the latest press. Today we have identified, Depomed, Inc. (NASDAQ:DEPO) due to the attention they received after this recent corporate development. …

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Clinical Psychiatry News - Generic gabapentin approved

admin — Wed, 31 Dec 2008 06:29:11 +0000

Gabapentin tablets (600 mg and 800 mg) are approved for adjunctive therapy in the treatment of partial seizures of epilepsy and postherpetic neuralgia. This product is the generic equivalent of Neurontin. For more information, contact Alpharma Inc. at 800-638-9096 or 800-645-4216.

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Product Management Today - New gabapentin generic

admin — Sun, 28 Dec 2008 19:44:59 +0000

Apotex Inc (Weston, Ontario, Canada), has introduced its oral gabapentin generic. In prescription strengths of 600 mg and 800 mg, gabapentin is approved for use as adjunctive therapy for patients with epilepsy and for the treatment of postherpetic neuralgia.

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Business Wire - Depomed Reports Dose Proportionality of Gabapentin GR at the Endocrine Society’s Annual Meeting

admin — Wed, 24 Dec 2008 02:26:36 +0000

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.
COPYRIGHT 2006 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

Medical Marketing and Media - Rulings may clear pathway for generic Neurontin, Paxil

admin — Thu, 18 Dec 2008 17:28:20 +0000

In mid-January, the FDA was close to a decision on pending applications for a generic form of Neurontin (gabapentin), based on a federal court’s complicated patent decision.The Washington, D.C., federal court directed the FDA to accept the ANDA submitted by Purepac, which is eligible for 180 days of exclusivity as the first sponsor. TorPharm was first to file on a different section of the patent, and is seeking shared exclusivity, according to a report.
Alpharma announced a favorable court ruling indicating that the company followed proper procedure in seeking approval for generic gabapentin, contrary to an FDA ruling that it had improperly filed its application. Teva and Eon also have pending “approvable” ANDAs and all are on hold awaiting results of ongoing litigation with Pfizer.

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Separately, a Philadelphia court issued a split ruling on a motion for summary judgment of non-infringement by Apotex on four “product-by-process” claims for GlaxoSmithKline’s Paxil (paroxetine.) The court granted the Apotex motion on most claims, but denied the others. GlaxoSmithKline reportedly has received five 30-month stays on Paxil patents since mid-1998.
Apotex said it views the decision as a victory since only one Paxil product claim remains, which is being reviewed; GSK said the judgment is a split decision and plans to appeal. Paxil, which had worldwide sales of close to $3 billion last year, has patent protection until 2006, according to GSK.
Copyright CPS Communications Feb 2003
Provided by ProQuest Information and Learning Company. All rights Reserved

M2 Presswire - Shareholders alert for Xenoport, Inc.

admin — Fri, 12 Dec 2008 13:15:21 +0000

M2 PRESSWIRE-25 April 2007-Biotech News: Shareholders alert for Xenoport, Inc.(C)1994-2007 M2 COMMUNICATIONS LTD RDATE:25042007 Shareholders alert for Xenoport, Inc. (NASDAQ:XNPT) Xenoport, Inc. operates as a biopharmaceutical company in the United States. It focuses on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transporter mechanisms.

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The company’s products include XP13512, a transported prodrug of gabapentin, which is in Phase 3 clinical trials for the treatment of restless legs syndrome; XP13512 for …

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News: Depomed Announces Allowance of Additional US Patent Covering …

admin — Wed, 10 Dec 2008 19:40:56 +0000

Depomed, Inc. (NASDAQ:DEPO) announced today that it has received a
Notice of Allowance from the U.S. Patent and Trademark Office for U.S.
patent application number 10/280,309.

Paul B. Simboli, Depomed’s director of Intellectual Property,
noted that the patent contains claims directed to methods for treating
neuropathic pain and claims related to methods for delivering
compounds via specific dosage form technologies.

Carl A. Pelzel, Depomed’s president and chief executive officer,
added, “This additional patent and the 67 newly allowed claims
significantly extend the patent portfolio around our two active
Gabapentin GR programs, one of which is currently in a pivotal Phase 3
clinical trial for the treatment of postherpetic neuralgia, and
another for the treatment of menopausal hot flashes which we expect to
advance into Phase 3 later this year.”

Subject to final issuance from the Patent and Trademark Office,
the newly allowed claims are expected to expire in 2024, taking into
account an anticipated patent term adjustment of at least 21 months.
In addition to the allowed U.S. patent application, a corresponding
patent has also been granted in Australia, and is pending in numerous
other countries.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company with two
approved products on the market and other product candidates in its
pipeline. The company utilizes its proven, proprietary AcuForm(TM)
drug delivery technology to improve existing oral medications,
allowing for extended, controlled release of medications to the upper
gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals
include the convenience of once-daily administration, improved
treatment tolerability and enhanced compliance and efficacy.
Glumetza(R) (metformin hydrochloride extended release tablets) is
approved for use in adults with type 2 diabetes. Proquin(R) XR
(ciprofloxacin hydrochloride) extended release tablets are approved in
the United States for the once-daily treatment of uncomplicated
urinary tract infections and will be marketed in the United States
within the urology specialty by Watson Pharmaceuticals. Product
candidate Gabapentin GR(R) is currently in clinical development for
the treatment of neuropathic pain and for menopausal hot flashes.
Additional information about Depomed may be found on its web site,
www.depomedinc.com.

“Safe Harbor” Statement under the Private Securities Litigation
Reform Act of 1995. Statements in this press release that are not
historical facts are forward-looking statements that involve risks and
uncertainties. The inclusion of forward-looking statements, including
those related to our intellectual property portfolio, and potential
benefits of our products and product candidates, should not be
regarded as a representation that any of our plans will be achieved.
Actual results may differ materially from those set forth in this
release due to the risks and uncertainties inherent in our business,
including, without limitation, risks and uncertainties related to: 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; our ability to
successfully commercialize our products; the success of our
collaborative arrangements with development and commercialization
partners; and other risks detailed in our filings with the Securities
and Exchange Commission filings, including our most recent Annual
Report on Form 10-K and our most recent Quarterly Report on Form 10-Q.
You are cautioned not to place undue reliance on these forward-looking
statements which speak only as of the date hereof. We undertake no
obligation to revise or update this release to reflect events or
circumstances that occur af

Medical Marketing and Media - Pfizer's Neurontin ad is misleading: DDMAC

admin — Fri, 05 Dec 2008 23:59:11 +0000

WASHINGTON INSIDER

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The Division of Drug Marketing, Advertising, and Communications (DDMAC) has ordered Pfizer Inc to discontinue use of Neurontin (gabapentin) promotional material depicting a human brain model because, DDMAC says, use of the model makes a “false” and “misleading” representation of Neurontin’s mechanism of action. The Division says that Pfizer’s model presented the human brain on one side and the other side contained headings and illustrations of cellular activity. The complaint centered around these presentations, which “suggest that the mechanism of action of Neurontin has been established in the human brain.”
Copyright CPS Communications Sep 2002
Provided by ProQuest Information and Learning Company. All rights Reserved

Business Wire - Court Rules for Pfizer in Patent Infringement Case on Neurontin

admin — Mon, 01 Dec 2008 19:25:11 +0000

NEW YORK — Pfizer Inc said today that an appeals court has overturned a lower court ruling that several generic manufacturers did not infringe the company’s patent for stabilized formulations of gabapentin, the active ingredient in Neurontin.
The Court of Appeals for the Federal Circuit ruled that the New Jersey federal district court should not have granted summary judgment to the generic manufacturers, and that a full trial should be held on Pfizer’s allegations of patent infringement.

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Pfizer said the ruling will allow the company to seek a judgment of infringement and, if successful, pursue full compensation for the damages it suffered due to the 2004 at-risk launch of generic versions of Neurontin. Prior to such launch, Pfizer’s sales of Neurontin were more than $2 billion a year, and the patent does not expire until 2017.
COPYRIGHT 2007 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

Women’s Health Advisor - A new way of seeing women’s depression symptoms: women may experience symptoms dubbed S.A.D. F.A.C.E.S

admin — Fri, 28 Nov 2008 19:25:55 +0000

Top Generics Based on Retail Dollar Sales

2006
RANK DRUG DOLLAR SALES

1 Hydrocodone/APAP $1,622,889,152
2 Simvastatin 1,390,478,902
3 Azithromycin 1,216,982,213
4 Oxycodone 1,179,858,560
5 Gabapentin 1,004,639,425

6 Amoxicillin/pot.

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clav. 926,015,426
7 Fexofenadine 905,379,076
8 Fentanyl …

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