Related Results

Risperdal approvalRisperdal okayRisperdal doseRisperdal clearedRisperdal request

* Comment: Approval was based on three 3-week studies of adults with bipolar I disorder, with manic or mixed episodes, with or without psychotic features. Two were monotherapy trials, and one used Risperdal with lithium or valproate. Treatment with Risperdal, alone or in combination, was significantly more effective than placebo in treating manic or mixed episodes. Risperdal “is a medication that works fast, is safe, and can be used very nicely in combination” with other drugs to treat bipolar patients, said Dr. Robert Hirschfeld, who was not an investigator but was involved in the analysis of the data. Last summer, the FDA approved the antiepileptic Lamictal (lamotrigine) and the atypical antipsychotic Zyprexa (olanzapine) for bipolar indications. These recent approvals are “very exciting,” considering that the only treatments available for bipolar disorder for many years were lithium and traditional antipsychotics, said Dr. Hirschfeld, professor and chair of the department of psychiatry and behavioral sciences at the University of Texas, Galveston. He is a consultant to and has received speaking honoraria from Janssen.
COPYRIGHT 2004 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Related Results

RisperdalRisperdal approvalRisperdal okayRisperdal doseRisperdal cleared

Risperdal was approved 15 years ago and generated $1.52 billion in revenue in the first half of this year. Prescriptions for the once-a-day pill fell 78 percent from June 27, the week before Teva Pharmaceutical Industries Ltd. began selling its low-cost generic version, and Aug. 1, according to Bloomberg data.
“If you look at the market for these drugs in general, there is a real need for more convenient dosing for patients,” said Linda Bannister, an analyst with Edward Iones & Co. in St. Louis. Patients often fail to take daily pills, she said.
Paliperidone palmitate could generate $500 million in annual sales by 2012, Bannister estimated. The number could change depending on the prospects for J&J’s other slow-acting schizophrenia medicine, Risperdal Consta, and for products that competing companies are developing, she said. Eli Lilly & Co. is testing a long-lasting version of its once-a-day Zyprexa, according to Bannister.
NEWER RISPERDAL
Risperdal Consta, a newer version of Risperdal, is injected in the buttocks twice a month. Alkermes Inc., the Cambridge, Mass., company that developed Risperdal Consta for J&J, is working on a monthly formulation of the drug.
Whether J&J will put its marketing strength behind paliperidone, a reformulated Consta, or both depends on how Consta does in clinical studies to be completed next year, said Dominic Caruso, J&J’s chief financial officer, on a conference call with analysts last month.
Antipsychotics were the sixth best-selling class of medications worldwide in 2007. Risperdal, Bristol-Myers Squibb Co.’s Abilify and Zyprexa generated $20.7 billion in sales last year, according to IMS Health, a market research firm in Norwalk, Conn.
Paliperidone palmitate uses the same chemical ingredient as J&J’s Invega, a schizophrenia tablet taken once a day. The monthly dose of paliperidone, injected in the arm, is simpler for patients, J&J spokesman William Price said in an e-mail.
TEVA COPIES
Teva, of Petah Tikva, Israel, began selling copies of Risperdal in June, after the J&J drug lost U.S. patent protection. Risperdal sales in the U.S. fell 9 percent in the second quarter as customers began making room in their inventories for the generic pill, Caruso said on the call. Sales dropped 37 percent in other countries, where the generic brand was already on the market.
Paliperidone’s patent protections expire in 2013 in the U.S. and 2017 elsewhere, said Louise Mehrotra, J&J’s vice-president for investor relations. Consta’s patents expire in 2014, though the longer-acting formulation would have protection until 2017.
Copyright Journal Publications Inc. Sep 1, 2008
Provided by ProQuest Information and Learning Company. All rights Reserved

Related Results

RisperdalRisperdal approvalRisperdal okayRisperdal doseRisperdal cleared

“These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients,” she says.
The FDA initially approved Risperdal fourteen years ago for the treatment of schizophrenia in the adult population.
COPYRIGHT 2007 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Most Popular
How To Write A Strategic Plan: A Simple Outline
Lethal Job Interview Mistakes
Top 10 Conflict Resolution and Communication Skills
5 Super Tips To Get Rid Of Your Public Speaking Fear: How To Overcome Public Speaking Anxiety
The Art Of Public Speaking: The Winning Path To A Successful Presentation

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

Related Results

RisperdalRisperdal approvalRisperdal okayRisperdal doseRisperdal cleared

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

Most Popular
Top 10 Conflict Resolution and Communication Skills
Lethal Job Interview Mistakes
5 Super Tips To Get Rid Of Your Public Speaking Fear: How To Overcome Public Speaking Anxiety
Job Interview: What Not To Do
How To Write A Strategic Plan: A Simple Outline

n

COPYRIGHT 2007 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Related Results

HaldolTrust, E-innovation and Leadership in ChangeForeign Banks in United States Since World War II: A Useful FringeBuilding Your Brand With Brand Line ExtensionsThe Impact of the Structure of Debt on Target Gains

The National Prescription Audit also showed that the prescription growth rate of Risperdal far exceeded that of its competitors. From July 1995 to July 1996, prescriptions for Risperdal increased by 80 percent, while prescriptions for all antipsychotics combined increased only six percent.
Since its introduction, Risperdal has become a standard of care in treating schizophrenia because of its combination of efficacy, safety and tolerability. It is the first serotonin dopamine antagonist (SDA) to receive marketing approval for first-line use in the treatment of schizophrenia.
“We’re proud that Risperdal has redefined the treatment of schizophrenia and other psychoses. In just two years, Risperdal has helped more than one million people regain control of their lives, and has continued to demonstrate a predictable safety and tolerability profile,” said Bruce Given, M.D., group vice president, Janssen Pharmaceutica. “Becoming the most prescribed antipsychotic is a vote of confidence from psychiatrists and patients who turn to Risperdal as a standard of care. Risperdal will continue to be a therapy of choice even when new agents become available.”
In June of this year, Janssen received clearance from the U.S. Food and Drug Administration to market an oral solution formulation of Risperdal. Due to its ease of administration, Risperdal Oral Solution will provide treatment benefits to a wider range of patients, particularly for the elderly, for whom liquid formulations are frequently prescribed, and for patients treated in an acute care setting.
Janssen is also conducting a clinical trial with Risperdal among elderly patients to support a safety claim in the product’s labeling, and is investigating the use of Risperdal in elderly patients suffering from psychotic symptoms. Because of safety concerns, not all antipsychotics are potential first-line therapies for the elderly. A number of factors need to be considered, including the metabolic profile of the drug, comorbidities, concomitant medications and the like.
“In addition to being well tolerated, Risperdal has not been associated with impaired cognitive function, such as cloudy thinking or impaired memory that can hamper a patient’s ability to reintegrate into society,” noted Dr. Given. “Reducing cognitive impairment is the next frontier of antipsychotic research, and Janssen is leading the way.”
Clinical studies have shown that the incidence of extrapyramidal symptoms (EPS) with Risperdal, while dose dependent, is comparable to placebo at recommended doses. The most common side effects reported in clinical trials were insomnia, agitation, EPS, headache, anxiety and rhinitis; less common were somnolence, dizziness, constipation, nausea and tachycardia. Risperdal may also cause orthostatic hypotension, a form of low blood pressure, especially during the initial dosing period.
Janssen continues to pursue advances for the treatment of illnesses associated with central nervous system (CNS) disorders. As part of Janssen’s commitment to CNS research, Janssen is currently investigating treatments in the area of Alzheimer’s disease, stroke, anxiety and depression. Janssen Pharmaceutica has companies in 32 countries. U.S. headquarters are in Titusville, N.J.
Please refer to complete prescribing information for Risperdal(R) (risperidone).
Editor’s Note: Interviews are available with physician experts and Janssen executives.
CONTACT: Ketchum Public Relations
Christopher Smith, 212/878-4655
or
Pallavi Damani, 212/878-4629
COPYRIGHT 1996 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

Related Results

RisperdalRisperdal approvalRisperdal okayRisperdal doseRisperdal cleared

[ILLUSTRATION OMITTED]
COPYRIGHT 2007 Society of Chemical Industry
COPYRIGHT 2008 Gale, Cengage Learning

“We are encouraged by the compelling preclinical profiles emerging
for this series of orally active, proprietary molecules, which
represent multiple opportunities to advance novel drug candidates into
our pipeline,” stated Daniel Deaver, Ph.D., vice president,
non-clinical development of Alkermes. “These findings support the
continued development of next-generation therapeutics to treat a broad
range of diseases, including central nervous system disorders and
brain reward disorders, such as addiction, obesity and other
impulse-control disorders.”

The study results presented today included efficacy data from an
ethanol drinking behavior model in rodents, a well-characterized model
for evaluating the effects of potential therapeutics targeting opioid
receptors. Results showed that single, oral doses of Alkermes’ novel
molecules significantly reduced the ethanol drinking behavior in
rodents, with an average reduction from baseline ranging from 35
percent to 50 percent for the proprietary molecules compared to 10
percent for the active control (P less than 0.05). Details from an
evaluation of the in vivo pharmacology, pharmacokinetics and in vitro
metabolism were also presented. Data showed that the molecules have
improved metabolic stability compared to the active control when
cultured with human hepatocytes (liver cells), suggesting that they
are not readily metabolized by the liver. Pharmacokinetic results
showed that the oral bioavailability of ALKS 33 was significantly
greater than that of the active control.

“Alkermes is focused on developing pipeline candidates with a high
likelihood of success compared to traditional new chemical entities.
These proprietary molecules reflect the broadening of our strategy to
utilize chemistry to improve known molecules to enhance outcomes,”
said Elliot Ehrich, M.D., chief medical officer of Alkermes.

Opioid modulators can act as agonists, antagonists or partial
agonists at opioid receptors in the brain. In addition to the
treatment of opioid and alcohol dependence, opioid dependence and
other addictions, opioid modulators are thought to have a number of
clinical applications, including the treatment of central nervous
system disorders and impulse-control disorders.

About Alkermes

Alkermes, Inc., a biotechnology company committed to developing
innovative medicines to improve patients’ lives, manufactures
RISPERDAL(R) CONSTA(R) for schizophrenia and developed and
manufactures VIVITROL(R) for alcohol dependence. Alkermes’ robust
pipeline includes extended-release injectable, pulmonary and oral
products for the treatment of prevalent, chronic diseases, such as
central nervous system disorders, addiction and diabetes.
Headquartered in Cambridge, Massachusetts, Alkermes has research and
manufacturing facilities in Massachusetts and Ohio. For more
information about Alkermes, visit http://www.alkermes.com.

Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to the potential
therapeutic value of Alkermes’ proprietary molecules targeting opioid
receptors and Alkermes’ plans to continue development of such
proprietary molecules. Although the company believes that such
statements are based on reasonable assumptions within the bounds of
its knowledge of its business and operations, the forward-looking
statements are neither promises nor guarantees and the company’s
business is subject to significant risk and uncertainties and there
can be no assurance that its actual results will not differ materially
from its expectations. For further information with respect to factors
that could cause the company’s actual results to differ materially
from expectations, reference is made to the reports the company filed
with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended. The forward-looking statements made
in this release are made only as of the date hereof and the company
disclaims any intention or responsibility for updating predictions or
financial expectations contained in this release.

VIVITROL(R) is a registered trademark of Cephalon, Inc.;
RISPERDAL(R) CONSTA(R) is a registered trademark of Janssen-Cilag
group of companies.