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DICLOFENAC POTASSIUM.Rofecoxib Is Faster and More Effective Than Diclofenac Sodium in Treating…NPS urges calm on diclofenac use.Diclofenac sodium topical gel for osteoarthritisEURAND RECEIVES APPROVAL TO MARKET GENERIC SODIUM DICLOFENAC.

This successful Phase 3 pivotal trial in 277 orthopedic surgical patients randomized subjects to receive one of three treatments every 6 hours: Dyloject 37.5 mg, ketorolac 30 mg, or placebo. The primary efficacy measure was the area under the curve of pain intensity across time, plotted as the difference from pretreatment pain compared to placebo. This area was examined stepwise across intervals of 0-24, 0-48, 0-72, 0-96, and 0-120 hours. Dyloject 37.5 mg had statistically significant differences compared to placebo for its primary endpoint across all five time intervals (P< 0.0001 for each of the five intervals). Dyloject’s efficacy was numerically although not statistically superior to ketorolac, which in turn was superior to placebo (P

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Roughly 10% of livestock carcasses in India are still seen to contain residues of diclofenac, says the RSPB’s Chris Bowden, head of the vulture recovery programme. ‘Monitoring vulture populations is a major undertaking but all the indications are that numbers are still going in the wrong direction.’
[ILLUSTRATION OMITTED]
The oriental white-backed vulture has already seen numbers decline 99.9% and long-billed and slender-billed vultures populations have fallen by 97% since 1992.
Research published by the Bombay Natural History Society earlier this year showed three species of Asian vulture could have only ten years to live unless diclofenac use on cattle was halted.
Another drug, meloxicam, is just as effective in treating cattle but is currently twice as expensive. Boehringer Inghleheim, the original developer of meloxicam, has pledged 42 000 to [pounds sterling] help further the RSPB’s vulture programme in India.
Until there is a prosecution, however, Bowden acknowledges that enforcement of the new rules may be difficult. The ban on the distribution and retail of the drug should make it easier to prosecute firms deliberately flouting the regulations, he says.
COPYRIGHT 2008 Society of Chemical Industry
COPYRIGHT 2008 Gale, Cengage Learning

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DICLOFENAC POTASSIUM.Rofecoxib Is Faster and More Effective Than Diclofenac Sodium in Treating…NPS urges calm on diclofenac use.Diclofenac sodium topical gel for osteoarthritisEURAND RECEIVES APPROVAL TO MARKET GENERIC SODIUM DICLOFENAC.

Methods: This prospective, double-arm, multicenter, open-label, phase 4 study was performed at 82 community dermatology centers in the US. A total of 714 subjects who had a clinical diagnosis of actinic keratosis with between 5 and 15 lesions contained in a target area such as the forehead, scalp, and hands were enrolled in the study. These subjects were randomized into 2 arms of the study: cryosurgery alone and cryosurgery followed by diclofenac sodium 3% gel for a period of 90 days. Lesion counts were assessed at baseline, and 45, 75, 105, and 135 days after cryosurgery.
Results: Of the 521 patients enrolled in the study who successfully completed all of the visits concluding on day 135, 277 were in the cryosurgery alone arm and 244 were in the cryosurgery followed by diclofenac sodium 3% gel arm. At the conclusion of the study, 46% of the subjects in the cryosurgery followed by the use of diclofenac sodium 3% gel arm achieved 100% cumulative (target plus new lesions) lesion clearance compared to 21% in the cryosurgery alone arm (P

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COPYRIGHT 2005 Circle Publishing Ltd.
COPYRIGHT 2008 Gale, Cengage Learning

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DICLOFENAC POTASSIUM.Rofecoxib Is Faster and More Effective Than Diclofenac Sodium in Treating…NPS urges calm on diclofenac use.Diclofenac sodium topical gel for osteoarthritisEURAND RECEIVES APPROVAL TO MARKET GENERIC SODIUM DICLOFENAC.

2005;41:707-716.
COPYRIGHT 2006 Association of Avian Veterinarians
COPYRIGHT 2008 Gale, Cengage Learning

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Side effects of treatment included application site reactions. The recommended dose of Voltaren gel is 4 g applied 4 times daily over joints of the lower extremities and 2 g applied 4 times daily over joints of the upper extremities. Total dose over all affected areas should not exceed 32 g/day.
Marissa Heller MD
Department of Dermatology, Boston University School of Medicine
Pipeline Previews brings you information on the newest drugs and medical products as they become available to the dermatologic community, including additional information from the manufacturers and physicians who wish to share their clinical experience with these new products. We will also inform you about the latest drugs receiving FDA approval.
COPYRIGHT 2008 Journal of Drugs in Dermatology, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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Read the rest of this article with a Free Trial at HighBeam Research.

The newly-released secondary endpoint data extends clinical
evidence that intravenous (IV) Dyloject offers safe, efficacious and
well-tolerated pain relief for abdominal and pelvic surgery. Patient
global evaluation scores and related measures of efficacy at 24 and 48
hours were statistically significantly higher than placebo for all
three arms of the study: Dyloject 18.75 mg and 37.5 mg and the active
comparator ketorolac 30 mg. Compared to the ketorolac group, the
Dyloject groups had a lower incidence of thrombophlebitis, and
numerically fewer adverse events associated with postoperative
bleeding.

Javelin’s Chief Medical Officer, Dr. Daniel B. Carr, and
colleagues made four additional presentations. Dyloject given IV in
clinically relevant analgesic doses to healthy volunteers in a Phase
1 study produced minimal interference with platelet function (ability
to clot), reaching only the upper limit of normal. Similar small
effects were seen with an oral diclofenac comparator, Cataflam(R). In
contrast, IV ketorolac and oral aspirin markedly disrupted platelet
function as measured by PFA-100 collagen-epinephrine closure time.
Similar findings were observed with collagen-ADP testing. The Phase 1
and pivotal Phase 3 results presented today add to prior pre-marketing
and early post-marketing experience that Dyloject, a balanced COX-1
and COX-2 inhibitor, poses less risk of bleeding than predominantly
COX-1 inhibitors such as ketorolac and aspirin.

Two additional presentations at the World Congress focused on
Rylomine(TM) and another featured Ereska(TM), respectively, Javelin’s
intranasal morphine and ketamine product candidates.

“We are very pleased to have had five Javelin posters accepted for
presentation at this prestigious World Congress on Pain meeting.
Especially timely are the presentations on Dyloject demonstrating its
safety, rapid efficacy, and convenience of use as it nears its ninth
month of marketing in the UK and, more recently, Scotland. We had
enthusiastic physician turnout at our Congress booth and
presentations. It’s been a very positive week for Dyloject and
Javelin,” stated Dr. Carr.

About Dyloject

Dyloject is an injectable formulation of diclofenac in Phase 3
clinical development in the United States and Marketed in the United
Kingdom. Diclofenac is a prescription nonsteroidal anti-inflammatory
drug (”NSAID”) that is widely prescribed to treat post-operative pain
due to its combination of effectiveness and tolerability. Dyloject has
the potential to provide an attractive alternative to other NSAIDs for
the treatment of post-operative pain, and to decrease the need for
morphine or other opioids in this setting. There still exists an
underserved medical need for a safe and effective injectable NSAID in
the hospital setting. In its pivotal UK registration trial, Dyloject’s
efficacy and safety were shown to be significantly superior to those
of the IV formulation of diclofenac currently marketed in the UK. Each
dose of the competitive formulation requires buffering, dilution and
slow infusion. Dyloject comes ready to use for immediate IV bolus
administration, works faster, and according to a recent study, has the
potential to save the UK NHS up to GBP 50 per postoperative patient.
This pharmacoeconomic benefit, coupled with Dyloject’s superior
clinical attributes, differentiates Dyloject from the competitive
diclofenac product, as well as from any of the other marketed IV NSAID
products. Dyloject is presently being marketed in the UK for the
treatment of acute moderate-to-severe pain. Subsequent submissions and
approvals in other European countries are anticipated through a
regulatory strategy following the Mutual Recognition Process.

About Javelin Pharmaceuticals, Inc.:

With corporate headquarters in Cambridge, MA, Javelin applies
innovative proprietary technologies to develop new drugs and improved
formulations of existing drugs to target unmet and underserved medical
needs in the pain management market. The Company has one marketed drug
in the UK and three drug candidates in US Phase 3 clinical
development. For additional information about Javelin, please visit
the company’s website at http://www.javelinpharmaceuticals.com.

Forward Looking Statement:

This news release contains forward-looking statements. Such
statements are valid only as of today, and we disclaim any obligation
to update this information. These statements are subject to known and
unknown risks and uncertainties that may cause actual future
experience and results to differ materially from the statements made.
These statements are based on our current beliefs and expectations as
to such future outcomes. Drug discovery and development involve a high
degree of risk. Factors that might cause such a material difference
include, among others, uncertainties related to the ability to attract
and retain partners for our technologies, the identification of lead
compounds, the successful preclinical development thereof, the
completion of clinical trials, the FDA review process and other
governmental regulation, our ability to obtain working capital, our
ability to successfully develop and commercialize drug candidates, and
competition from other pharmaceutical companies.

JAV-G

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“The main drawback of commonly used oral anti-inflammatory medications is
that many people cannot tolerate them,” said Robert Sheu, M.D., Director of
the Pain Division, Department of Pain Medicine and Palliative Care, Beth
Israel Medical Center, New York. “There are a lot of physicians and
patients who would prefer a more targeted approach to treating pain at the
site of an injury, and a topical patch accomplishes this while avoiding the
stomach and digestive tract.” Studies have shown that up to 50 percent of
patients who suffer from pain have intolerance to traditional oral NSAIDs.
(1)

Acute pain is a common problem with one in four Americans suffering an
episode of pain lasting longer than 24 hours. (2) FLECTOR Patch is
indicated for the topical treatment of acute pain due to minor strains,
sprains and contusions.

In a national survey released today by the National Pain Foundation (NPF),
supported by a grant from Alpharma Pharmaceuticals LLC, 93 percent of
survey respondents expressed that people take too many pills, and 82
percent said they would be interested in a prescription pain relief patch
that delivers medication directly to the point of pain. Further reinforcing
the need for new pain relief therapies, the survey shows that only 22
percent of people were very satisfied with the current method they used to
treat their pain. (3)

About FLECTOR Patch

Each FLECTOR Patch measures approximately 4 inches by 5.5 inches and
contains 180 mg of diclofenac epolamine, which has demonstrated both
anti-inflammatory and analgesic (pain-relieving) activities. The
recommended dose of FLECTOR Patch is one patch to the most painful area
twice a day (12 hours at a time). FLECTOR Patch should be applied to
intact or
non-damaged skin.

The prescribing information does not specify a limit on the duration of use
for FLECTOR Patch; however, it should be used at the lowest effective
dose for the shortest duration consistent with individual patient treatment
goals.

FLECTOR Patch delivers significant pain relief with no serious adverse
events observed in clinical trials for up to two weeks with approximately
600 patients. In addition, the incidence of gastrointestinal side effects
such as nausea and upset stomach were comparable to placebo patch.

In the controlled trials, three percent of patients in both the FLECTOR
Patch and placebo patch groups discontinued treatment due to an adverse
event. The most common adverse events leading to discontinuation were
application site reactions, occurring in two percent of both the FLECTOR
Patch group and the placebo patch group.

Outside the U.S., the diclofenac patch has an extensive track record of
safety, having been introduced in Switzerland in 1993, and is currently
approved in 43 countries. No serious adverse events or fatalities have
been reported, despite use in more than six million patients and totaling
approximately 175 million patches.

Contraindications and Safety Information

NSAIDs may cause an increase risk of serious cardiovascular thrombotic
events, myocardial infarction, and stroke which can be fatal. This risk may
increase with duration of use. Patients with cardiovascular disease or risk
factors for cardiovascular disease may be at greater risk.

FLECTOR Patch is contraindicated for the treatment of perioperative pain
in the setting of coronary artery bypass graft (CABG) surgery, and in
patients with known hypersensitivity to diclofenac.

NSAIDs cause an increased risk of serious gastrointestinal adverse events
including bleeding,
ulceration, and perforation of the stomach or intestines, which can be
fatal. These events can
occur at any time during use and without warning symptoms. Elderly patients
are at greater risk
for serious gastrointestinal events.

FLECTOR Patch should not be given to patients who have experienced
asthma, urticaria, or allergic-type reactions after taking aspirin or other
NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have
been reported in such patients.

FLECTOR Patch labeling contains similar warnings and precautions as
other NSAIDs (ibuprofen, naproxen). Please see complete prescribing
information for FLECTOR Patch or visit www.FlectorPatch.com for more
information.

About Alpharma

Arthritis patients who take the COX-2 inhibitor etoricoxib experience fewer incidence of upper gastrointestinal clinical events, symptoms and problems, than in patients who took the NSAID* diclofenac, according to an Article in The Lancet.

This information will assist with the treatment of arthritis, and when physicians need to make decisions concerning pain management.

NSAIDS are a long term arthritis treatment. However, they increase the risk of upper gastrointestinal clinical problems including, but not exclusive to, bleeding ulcers. Previous trials did not simulated standard clinical practice because gastrointestinal protective therapies like proton pump inhibitors (PPIs) were not allowed.

Loren Laine (University of Southern California Keck School of Medicine, Los Angeles, USA) and colleagues analyse data from three randomised trials from the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term) programme to assess the effects of the two drugs in a setting that simulates real-world practice, in patients with gastrointestinal risk.

Upper gastrointestinal clinical problems were less common with etoricoxib than with diclofenac, but only in simple cases. The more serious complicated events showed no significant difference whether patients took PPIs or asprin.

The authors of the study concludes: “The results of the MEDAL programme provide new information about upper gastrointestinal clinical events and symptoms to assist arthritis patients and their physicians to make decisions regarding NSAID use.”

In an accompanying Comment, Joost Drenth and Freek Verheugt (Radboud University Nijmegen, Netherlands) stated in an email, unofficially: “Though eterocoxib reduced upper gastrointestinal events, the effect was only small as 259 patients need to be treated to prevent one uncomplicated gastrointestinal event. The alternative, addition of a PPI to standard NSAID might be less expensive, potentially less cardiotoxic, and advantageous in terms of reducing dyspepsia, but here confirmation needs a randomised trial.”

Arthritis can drastically reduce the quality of life. Suffering from gastric problems, caused by drugs, can further reduce the quality of life. There is relief for arthritis patients, but they need to consult their physician before changing drugs or embarking on a pain management program.

Pain can help arthritic patients understand what is wrong with their bodies and correct the problem instead of masking the pain. There are supplements and practices that will help reduce the joint damage and inflammation that causes many types of arthritis.

Jumping on every new drug study may have negative effect on the body. Patients suffering from joint pain need to understand that other factors, like stress and weight, will cause arthritis and the level of pain suffered.

However, patients who are suffering from gastric problems may find some relief in the results of this test. It may give their physician an alternative to their current pain management program.

Patient empowerment is a strong element in patient care today and patients are encouraged to research pain management programs and make suggestions that fit their lifestyles, while still working with their physician’s program and techniques.