Unlike other drugs to treat alcoholism, topiramate, or Topamax, does not require people to stop drinking before starting treatment, the study’s authors write in today’s Journal of the American Medical Association.

In addition, treatment required a weekly 15-minute counseling session, done by nurses in the study.

“This is a drug that can be given to people in crisis,” says lead author Bankole Johnson, psychiatry chair at the University of Virginia.

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Men and women ages 18 to 65 participated in the 14-week study. Researchers randomly assigned 183 to topiramate pills and 188 to placebo pills. In the first five weeks, the daily dose of topiramate gradually increased from 25 to 300 milligrams.

Patients on the placebo pills also began drinking less, the study found. …

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Other similarities between the drug products cited by the manufacturers include abbreviations in computerized listings incorporating the first three letters and dose of both names, identical dosage strengths and identical starting doses.
“Another example of errors of similarly named medications involved reports of confusion between Rozerem and Razadyne,” say the companies. “Both drug products are available as 8-mg tablets.
“Prescribing mistakes between different formulations for a given medication have been reported and led to improper administration of the medication by patients and caregivers. An example involves the immediate-release and extended-release formulations of Razadyne.”
The immediate-release tablet is to be administered twice daily; the extended-release capsule (Razadyne ER), once daily. Factors that may have contributed to medication errors include omission of the formulation on the prescription order and incorrect administration directions from the prescriber (e.g., twice daily dosing for extended-release formulation instead of once daily for extended release and vice versa).
Suggestions for pharmacists are also offered by the companies.
“Although potential medication errors have multiple symptom causes, the role of the pharmacist in avoiding such errors is pivotal,” they point out. “Increased awareness of prescribing and dispensing medication errors, combined with incorporating additional verification measures, can most likely prevent medication errors.
“It is important for all health care professionals to take an active role in the medication use process. With more patients taking a greater number of medications, increased awareness of prescribing and dispensing confusion between similar drug products can help to minimize the occurrence of these errors.”
COPYRIGHT 2006 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

DOLLAR % CHANGE
SALES MARKET VS. YEAR
PRODUCT COMPANY (000) SHARE AGO

Lipitor Pfizer $8,100 2.8% -7%
Nexium AstraZeneca 5,471 1.9% 6%
Advair Diskus GlaxoSmithKline 4,251 1.5% 7%
Plavix BMS Sanofi 3,926 1.4% 33%
Seroquel AstraZeneca 3,457 1.2% 14%
Singulair Merck 3,445 1.2% 14%
Enbrel Amgen 3,423 1.2% 11%
Prevacid TAP Pharmaceutical 3,366 1.2% -7%
Aranesp Amgen 3,188 1.1% -19%
Epogen Amgen 3,073 1.1% -5%
Neulasta Amgen 3,066 1.1% 5%
Actos Takeda 2,929 1.0% 12%
Effexor XR Wyeth-Ayerst 2,867 1.0% 8%
Remicade Centocor 2,803 1.0% 10%
Lexapro Forest 2,637 0.9% 9%
Risperdal Janssen 2,627 0.9% 3%
Protonix Wyeth-Ayerst 2,514 0.9% 5%
Vytorin Merck/Schering-Plough 2,488 0.9% 34%
Zyprexa Lilly 2,418 0.8% 0
Lovenox sanofi-aventis 2,393 0.8% 12%
Procrit Ortho Biotech 2,385 0.8% -18%
Abilify Otsuka America 2,368 0.8% 22%
Rituxan Genentech 2,275 0.8% 10%
Avastin Genentech 2,245 0.8% 32%
Topamax McNeil 2,150 0.8% 18%
Lamictal GlaxoSmithKline 2,114 0.7% 25%
Cymbalta Lilly 1,959 0.7% 57%
Fosamax Merck 1,889 0.7% -4%
Zetia Merck/Schering-Plough 1,855 0.6% 20%
Celebrex Pfizer 1,799 0.6% 7%
Crestor AstraZeneca 1,717 0.6% 30%
Aricept Eisai 167 0.6% 20%
Humira Abbott 1,636 0.6% 35%
Zyrtec Pfizer 1,632 0.6% 10%
Lantus sanofi-aventis 1,605 0.6% 23%
Valtrex GlaxoSmithKline 1,604 0.6% 20%
Levaquin McNeil 1,545 0.5% 4%
Avandia GlaxoSmithKline 1,443 0.5% -36%
Diovan Novartis 1,417 0.5% 14%
Tricor Abbott 1,383 0.5% 12%
Eloxatin sanofi-aventis 1,378 0.5% 9%
Flomax Boehringer Ingelheim 1,332 0.5% 25%
Herceptin Genentech 1,298 0.5% 6%
Imitrex GlaxoSmithKline 1,296 0.5% 7%
Adderall XR Shire US 1,282 0.4% 12%
Aciphex Eisai 1,275 0.4% -2%
Coreg GlaxoSmithKline 1,264 0.4% -18%
Diovan HCT Novartis 1,260 0.4% 20%
Copaxone Teva Neuroscience 1,204 0.4% 19%
Avonex Biogen ldec 1,186 0.4% -2%

Source: IMS Health, National Sales Perspectives, December 2007.

COPYRIGHT 2008 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Scientists who evaluated 203 women who became pregnant while taking topiramate, generic for Topamax, reported that of 178 babies born, 16 had major birth defects, including cleft palate and other malformations. Three of the 16 babies born with defects had mothers who were taking only topiramate, and the 13 others had mothers on topiramate and other anti-epilepsy drugs.

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Four of the babies were born with cleft palates or cleft lips, a rate 11 times higher than normal. Four male babies had genital birth defects, 14 times higher than the normal rate, …

Read the full article with a Free Trial at MyWire.

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Addiction specialists not involved in the study said the findings are promising, although side effects such as trouble concentrating, tingling and itching caused about one in five people to drop out of the study. Drowsiness and dizziness are also problems.
“The size of the treatment effect is larger than in most of the other medications we’ve seen,” said Dr. Mark Willenbring of the National Institute on Alcohol Abuse and Alcoholism. “And all the drinking variables changed in the right direction.”
The study, published in today’s Journal of the American Medical Association, was funded by the maker of the drug, Johnson & Johnson Inc.’s Ortho-McNeil Neurologics. The researchers also reported financial ties to the company. Ortho-McNeil reviewed the manuscript, but did not change the results or interpretation, the researchers reported.
The study followed 371 heavy drinkers for 14 weeks. About half were randomly assigned to take Topamax, also called topiramate, in gradually increasing doses. The others took dummy pills.
All volunteers were encouraged — but not required — to stop drinking.
At the start of the study, they drank, on average, 11 standard drinks daily. That’s about two six-packs of beer each day, or two bottles of wine, or a pint of hard liquor.
By the end of the study, 27 of the 183 people, or 15 percent, who took Topamax had quit drinking entirely for seven weeks or more. That compared to six out of 188, or 3 percent, in the placebo group.
Others cut back. The Topamax group cut back to six drinks a day, on average, assuming everyone who dropped out of the study relapsed into heavy drinking. That compared to seven drinks a day for the placebo group.
“You can come in drinking a bottle of scotch a day and get treatment without detox,” said Dr. Bankole Johnson of the University of Virginia, who led the study, which was conducted at 17 U.S. sites from 2004-2006.
The study didn’t follow the drinkers long-term, so it’s unclear how many relapsed after they stopped taking the pill.
But there were lasting effects for Tom Wolfe, 44, a carpenter from Earlysville, Va., who said he has been sober for two years thanks to Topamax. After years of heavy drinking, he took part in an earlier Topamax study. He felt “a little lightheaded” at first until he got used to the drug. Alcohol lost its enjoyment, strengthening his resolve to quit.
The drug works by inhibiting dopamine, the brain’s “feel-good” neurotransmitters that are involved in all addictions, said Stephen Dewey, a neuroscientist the Brookhaven National Laboratory, who was not involved in the study but does similar research.
It’s a new approach, he said, that “clearly did work on a very small subset in the population.”
Willenbring, who wrote an accompanying editorial, predicts that a future pill, although probably not Topamax, will do for alcohol dependence what Prozac did for depression: Remove the stigma.
Prozac changed the nature of depression treatment 20 years ago by allowing patients to see their family doctors for help, Willenbring said. An effective drug with few side effects could do the same for alcoholism treatment, he said.
“This is a huge market,” Willenbring said. “We’re approaching a Prozac moment.”
But Topamax has big obstacles. With the drug maker’s patent expiring next year, there won’t be any big push to advertise it for alcoholism, Willenbring said.
Doctors are free to prescribe drugs for uses that have not been approved, but drug companies are prohibited by law from marketing drugs for these so-called “off-label” uses.
On Tuesday, Dr. Sidney Wolfe, director of Public Citizen’s health research group, sent a protest letter to the U.S. Food and Drug Administration questioning the promotion of Topamax for alcoholics by researchers funded by Ortho-McNeil.
“This is a very bad message to send out,” Wolfe said.
Ortho-McNeil has no plans to seek federal approval for the drug as an alcoholism treatment, said company spokeswoman Tricia Geoghegan. The company dropped development of new uses for the drug in 2004, but has continued to support some research.
——
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However, a name change was not included among the suggested safety precautions in a “Dear Health Care Provider” letter sent out by Ortho-McNeil Pharmaceutical Inc., maker of Topamax.
Reports of mixups between Topamax and Toprol-XL (AstraZeneca) have been submitted to the Food and Drug Administration, the World Health Organization, and the U.S. Pharmacopeia, an Ortho-McNeil press release said. The reports document prescriptions that have been incorrectly written, labeled, and/or dispensed, resulting in patients taking the wrong drug.
Neither company would say how many medication errors have been reported, but the press release did say such errors can lead to “potentially serious health consequences associated with either unintended exposure to a medication or lack of a needed therapy.” Patients taking topiramate, an anticonvulsant, can experience a sudden increase in seizure activity, and those taking metoprolol succinate, a [beta]-blocker, can experience increases in blood pressure, angina, or even myocardial infarction if therapy stops abruptly.
The errors have been traced not only to similarity in trade names, but also to the products’ proximity on pharmacy shelves or computerized listings, and identical dose strengths in the tablet formulations. Both drugs also recommend dosage titration, which could be another contributing factor, according to Ortho-McNeil’s “Dear Health Care Provider” letter, which is part of the company’s educational campaign targeted at physicians and pharmacists.
To help ensure that patients receive the correct medication, the campaign encourages physicians to:
* Be alert to the possibility of medication errors in patients prescribed Topamax or Toprol-XL.
* Be aware of the possibility of medication errors in patients presenting with unexpected signs or symptoms while on Topamax or Toprol-XL.
* Confirm the brand and generic names and dosage on written and oral prescriptions.
* Print legible prescriptions that include the brand names and generic names, with indication.
* Counsel patients about the brand name, indication, and proper use of each medication.
Neither Ortho-McNeil nor AstraZeneca has announced plans to alter its drug’s trade name in any way. In the absence of such changes. Mr. Cohen suggested that physicians take the initiative to explain the situation to patients and highlight the drug names in a way that makes the prescription very clear to the pharmacist. Such an effort helps patients advocate for their own safety, he said. “Doctors should highlight the unique letter characters in each name, and also take a few minutes to let their patients know that there have been some mistakes.”
Additionally, he said, pharmacists dispensing the medications can easily catch any errors with a few words to the person picking up the medication. “All they have to do when handing it out is to repeat the name of the drug to the patient and ask, in the case of Topamax, for example, ‘Are you using this for seizures or migraines?’”
BY MICHELE G. SULLIVAN
Mid-Atlantic Bureau
COPYRIGHT 2005 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

TopamaxTopamax indicationTopamax cleared by FDATopamax approved for new indicationTopamax

> Topamax has been granted pediatric exclusivity from the Food and Drug Administration. The Ortho-McNeil Neurologics product is indicated as initial monotherapy in patients ages 10 and older with partial-onset seizures. The new FDA designation extends the exclusivity of Topamax–which is also indicated as an adjunctive therapy for adults and children (2 and older) with partial-onset seizures–through March 2009.
COPYRIGHT 2008 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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COPYRIGHT 2001 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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“We believe that Robert’s experience in successfully transitioning therapeutic candidates from research to clinical trials and the strategic management of clinical development programs for pain indications is an ideal fit for NeurAxon,” stated Lawrence Bloch, M.D., J.D., Chief Executive Officer of NeurAxon. “Robert has been instrumental in the clinical development and approval of several products, including Topamax([R]) for migraine prevention and analgesics including Vicoprofen([R]), Ultracet([R]), Zaldiar([R]) and Duragesic([R]) (pediatric). We look forward to Robert applying his broad expertise to our promising pipeline of next generation pain therapeutics as we plan additional clinical trials for our lead program, NXN-188 for migraine, and as we bring additional product candidates from the NeurAxon portfolio into the clinic.”
“As a physician and a migraineur myself, I appreciate that there are significant unmet medical needs in the treatment of migraine as well as other pain indications, and I believe that NeurAxon’s approach through the inhibition of neuronal nitric oxide synthase has great promise,” commented Robert Medve, M.D. “For example, the dual mechanism of action of NeurAxon’s lead candidate, NXN-188, through nNOS inhibition and 5HT agonism has the potential to provide substantial improvements over the current standards of care for the treatment of acute migraine. I am enthusiastic about being part of the NeurAxon leadership team and contributing to the development of these exciting drug candidates.”
In addition to Lifetree Clinical Research, Dr. Medve has held senior positions in pharmaceutical and biotechnology companies including Metaphore Pharmaceuticals, Johnson & Johnson and Knoll Pharmaceutical Company. He has extensive experience in managing pre-clinical and clinical drug development programs and has leadership experience in all aspects of regulatory interaction in the US and Europe. Dr. Medve earned his doctorate of medicine at Jefferson Medical College in Philadelphia, Pennsylvania, and he completed his residency in the anesthesia department at Thomas Jefferson University Hospital. Dr. Medve completed a pain management fellowship at Roswell Park Cancer Institute and the Children’s Hospital of Buffalo, where Dr. Medve also served as the Director of Pediatric Pain Management.
Topamax([R]) and Ultracet([R]) are registered trademarks of Ortho-McNeil Neurologics, a division of Johnson & Johnson.
Vicoprofen([R]) is a registered trademark of Knoll Pharmaceutical Company, an Abbott Laboratories Company.
Zaldiar([R]) is a registered trademark of Grunenthal.
Duragesic([R]) is a registered trademark of Janssen, a Johnson & Johnson Company.
About NeurAxon Inc.
NeurAxon Inc. (www.nrxn.com) is a leader in discovering and developing next generation pain therapeutics targeting neuronal nitric oxide synthase (nNOS), an enzyme involved in modulating pain and central nervous system neuronal sensitization.
COPYRIGHT 2007 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning