Tranzyme Pharama

Tranzyme Pharma’s drug candidate would be an alternative to a drug for gastroparesis that now carries a black box warning. Reglan (metoclopramide) is a prescription treatment for gastroparesis that just recently received an FDA black box warning following reports that linked the medication to a serious and involuntary movement disorder known as Tardive Dyskinesia. A black box warning is the most serious type of warning the agency can issue and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse events.

Alternatively, Tranzyme Pharma reported that all three doses of TZP-102 were effective, safe and well tolerated by participants in the clinical trial. The company is now gearing up for a 12-week study to test the drug’s efficacy and safety in patients who have gastroparesis.

Last month, Tranzyme Pharma announced an agreement with Netherlands-based Norgine to develop and commercialize TZP-101, another treatment for gastrointestinal disorders.

SOURCE: Reglan Side Effects › Diabetic gastroparesis treatment shows well in clinical trials

Generic drug makers successfully argued in district court that a Food and Drug Administration  (FDA) regulation that required generic drugs to carry the same labels as their brand-name equivalents conflicted with the failure-to-warn claims. However, the Eighth Circuit Court overturned the dismissal resulting in a victory for Mensing.

It proved too late for Mensing, but earlier this year the FDA issued a black box warning for Reglan (metoclopramide), advising physicians to avoid long-term use of the drug except in rare cases where the benefit outweighs the risks. Long-term users and elderly patients, especially women, are at an increased risk for developing the serious movement disorder. There is no known cure for Tardive Dyskinesia, even after the medication has been discontinued.

Patients currently taking Reglan or the generic metoclopramide should discuss any risks or side effects with their health care provider.

SOURCE: Reglan Side Effects › Makers of generic Reglan liable for inadequate warning labels

Salix Pharmaceuticals’

Marketing for Metozolv was approved last September by the Food and Drug Administration (FDA) for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. It also is the first orally disintegrating tablet formulation for both acute and recurrent diabetic gastroparesis.

“We are very proud to achieve the FDA approval of Metozolv ODT,” said Eugene T. Haley, CEO of Wilmington Pharmaceuticals, developers of Metozolv. “We’re especially pleased that the application of Catalent’s Zydis technology to this proven medication may enhance the lives of patients for years to come. Metozolv’s success further validates the commercial attractiveness of fast-dissolving dosage forms and illustrates the significant inherent value in bringing together a game-changing drug delivery technology with product development expertise and a top notch sales and marketing organization.”

While approved by the FDA, Metozolv carries the same black box warning as other metoclopramide products, such as Reglan. The medication fell under the warning earlier this year after numerous reports of a serious movement disorder known as Tardive Dyskinesia were linked to long-term use of metoclopramide.

Source: Reuters

SOURCE: Reglan Side Effects › New GERD, gastroparesis treatment uses fast-dissolve technology

According to researchers at the Feinstein Institute, there are two separate pathways in the brain that influence the severity of the symptoms of movement disorders. All individuals who carry the mutations and symptoms for dystonia have an abnormal pathway between the cerebellum and the thalamus. These patients also have a normal second pathway between the thalamus and the cortex. However, researchers found that patients who have the mutation in the first pathway as well as in the second pathway have no symptoms of dystonia. In effect, the two defects seem to cancel each other out.

Researchers say this could be promising news to individuals who suffer from various movement disorders, from Parkinson’s disease to Tardive Dyskinesia, a condition that results from long term use of medications such as metoclopramide, a treatment for GERD and gastroparesis, and antidepressants.

One surgical treatment for both that has shown promising improvements in motor symptoms is known as deep brain stimulation, or DBS. Which leads researchers to ask, does abnormal brain wiring improve dystonia the same way as DBS?

Source: Brain Blogger

SOURCE: Reglan Side Effects › Brain mutation may prevent movement disorders

Salix Pharmaceuticals, Ltd

Gastroparesis, or delayed emptying of the stomach contents, affects nearly 1.5 million people and can cause pain, bloating, vomiting and malnutrition. GERD, or gastroesophageal reflux disease, affects approximately one-third of the U.S. population. Metozolv ODT is designed for sufferers of both conditions who have difficulty swallowing, need treatment but do not have water available, or need a portable way to take medication. Metozolv ODT rapidly melts on the tongue and gives patients an alternative to the pill form of metoclopramide.

Metozolv ODT will carry the same black box warning as the brand name metoclopramide, Reglan, which warns users that long-term therapy (12 weeks or longer) increases one’s risk of a serious involuntary movement disorder known as Tardive Dyskinesia. The condition is disabling and does not usually go away once treatment with metoclopramide has stopped.

Metozolov ODT packaging will also warns users that the drug should be used with caution in patients showing acute dystonic reactions, drug-induced Parkinsonism, or other extrapyramidal symptoms, and neuroleptic malignant syndrome with a prior history of depression.

Last week, in anticipation of the FDA’s approval, Salix announced that it will increase its sales force by 60 percent to help market Metozolov ODT. The drug has patent protection until 2017, and additional patent protection pending that, if issued, could provide patent protection until 2025.

Source: Reuters

SOURCE: Reglan Side Effects › Salix receives FDA approval to market new metoclopramide drug

Tranzyme Pharma’s

TZP-102 is an oral medication. Tranzyme’s equivalent medication, TZP-101, a drug given by IV in a hospital setting, has been put on hold by the company. While the drug showed promising results in phase II trials, the company hopes to buy time until the markets improve and the cost of capital drops.

Diabetic gastroparesis is a disorder in which the stomach takes too long to empty its contents. It affects people with both type 1 and type 2 diabetes. The condition is often treated with metoclopramide, sold in the U.S. under the brand name Reglan. Earlier this year, the FDA required manufacturers of metoclopramide to put a black box warning on the  medication warning health care providers and consumers of the risk of a serious involuntary movement disorder known as Tardive Dyskinesia.

Patients who suffer from Tardive Dyskinesia experience such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips and involuntary movements of the fingers. The condition is often irreversible even after medication has been stopped.

Analysts say a new treatment for diabetic gastroparesis would be welcome in an area where few treatments are currently available.

Source: Biz Journals

SOURCE: Reglan Side Effects › New treatment for gastroparesis granted FDA ‘fast-track’ status

Earlier this year the FDA placed a black box warning – the sternest warning it can require –on Reglan after reports of users of Reglan began suffering from a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. Those who suffer from the condition develop involuntary movements of the muscles, such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

Those who take Reglan for more than 12 weeks are at greater risk of developing Tardive Dyskinesia, thus the new labeling advises against long-term use except in rare cases where the benefit outweighs the risks.

Given the black box warning now on Reglan, sufferers of digestive problems may want to turn to old-fashioned, natural alternatives. For example, ginger root aides in digestion and licorice root soothes mucous membranes along the GI tract. Peppermint settles the stomach and aides in the production of saliva. And Rubarb works to rid excessive mucous in the intestines.

For more information, visit your local health food store. And always be sure to discuss any medication or diet changes with your health care provider.

Source: Examiner

SOURCE: Reglan Side Effects › Reglan users may want to consider natural remedies

Metoclopramide accelerates food absorption and may slow the emptying of solids, thus diabetics may need to increase insulin doses. The drug also may reduce the absorption of medications, such as the heart medication digoxin. The drug also has been linked to a serious movement disorder known as Tardive Dyskinesia. Concurrent use of phenothiazine and butyrophenone tranqulizers should be avoided because they increase the potential for Tardive Dyskinesia. The condition causes involuntary muscle spasms, motor restlessness and inappropriate aggression.

Earlier this year the Food and Drug Administratin (FDA) issued a black box warning on Reglan (metoclopramide) for the risk of Tardive Dyskinesia with long-term use of the medication. The elderly are at higher risk of experiencing side effects, in particular Tardive Dyskinesia. Dosage may need to be adjusted in older patients with impaired kidney function. Children may experience muscles spasms and Tardive Dyskinesia as well as blood problems if they take high doses of the medication.

Individuals who have suffered side effects after taking Reglan (metoclopramide) should contact their physicians. They may also have a lawsuit against the manufacturers of the medication.

The Merck Veterinary Journal
iVillage: Your Total Health

SOURCE: Reglan Side Effects › Prokinetic drugs like Reglan have list of side effects

While researchers are calling this encouraging news to pregnant women, the U.S. Food and Drug Administration (FDA) says more studies must be conducted before the agency will grant approval for the drug to be used in the treatment of morning sickness. After all, the drug carries a black box warning to consumers and health care providers of a serious, debilitating and often irreversible movement disorder called Tardive Dyskinesia. Other problems, it appears, may occur when the medication is taken on a long-term basis, even for pregnant women. 

According to the Canadian research, the length of time on the drug seemed to play a role in the likelihood of birth defects. Children from mothers who took the drug just one week during the first trimester had a 4.9 percent birth defects rate, while babies from mothers who used the drug for more than three months had a 6.1 percent rate of birth defects.

Reglan is approved in the U.S. by the FDA to treat heartburn and a condition known as diabetic gastroparesis. Earlier this year, the FDA issued a black box warning on the medication warning of the increased risk of Tardive Dyskinesia. Individuals who take the medication for longer than 12 weeks are at greatest risk of developing the condition. Elderly women, especially women, are also at greater risk than the general population. Some studies put the risk as high as 20 percent among long-term uses of Reglan.

Source: Calorie Lab

SOURCE: Reglan Side Effects › Study: Effect of Reglan on increased risk of birth defects

Earlier this year the FDA ordered all makers of metoclopramide to provide a risk evaluation and mitigation strategy (REMS) following reports linking the drug to a serious condition in which a person develops involuntary movements of his muscles known as Tardive Dyskinesia. Those taking the medication for more than 12 weeks, elderly patients, and women are at an increased risk of developing the severe adverse reaction. There is no know cure for Tardive Dyskinesia and symptoms may persist even after the medication has been discontinued.

As a result of the REMS, the FDA elevated the warnings to a boxed warning on package inserts of metoclopramide warning of the risks associated with long-term use. Metoclopramide is perhaps most known in the U.S. by the brand name Reglan. An estimated 2 million American use some form of metoclopramide.

Source: Seeking Alpha

SOURCE: Reglan Side Effects › Salix metoclopramide drug moves closer to FDA approval

Reglan, also known as metoclopramide, is generally prescribed to treat diabetic gastroparesis in adults and gastroesophafeal reflux in adults and children. Recent clinical studies have shown that it is safe for the treatment of morning sickness in women who are pregnant. However, a recent FDA warning has made people like Fiestagrill question whether the medication is causing serious injury to babies as well as children.

The FDA recently issued a black box warning – the strongest warning the FDA can require – on Reglan (metoclopramide) after reports of serious and debilitating side effects from people who were taking the medication over an extended period of time. The condition, known as Tardive Dyskinesia, is an involuntary movement of muscles that can include lip smacking, tongue thrusting, eye blinking and buldging, head jerking, facial grimacing, puckering and pursing of the lips and involuntary movements of the fingers. The condition often lingers even after the medication has been discontinued, causing serious disability.

Currently, the makers of Reglan are facing numerous lawsuits by individuals who have been harmed by the medication and are seeking justice. Could Jessica be another victim of Reglan?

Watch the video below.

SOURCE: Reglan Side Effects › Are Baby Jessica’s head jerks a side effect of Reglan?

Questcor Pharmaceuticals Inc

Diabetes is just one of the known causes of gastroparesis. The condition is generally treated through dietary changes and medications including metoclopramide, which is commonly found under the brand names Reglan, Maxolon or Clopra and is traditionally available in the form of a tablet,  oral solution or injection.

The clinical trail on Questor’s Emitasol metoclopramide nasal spray showed encouraging results in terms of safety and preliminary evaluation of efficacy in the treatment of diabetic gastroparesis. No serious adverse events were reported during the trial.

In recent months, the Food and Drug Administration (FDA) placed a black box warning on the drug metoclopramide – the strongest warning required by the FDA – after a serious condition called Tardive Dyskinesia was reported in a number of patients who took the drug. Tardive Dyskinesia is a Parkinson’s-like condition in which a person develops involuntary movements of his muscles, including lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, lip puckering and involuntary movements of the fingers. The condition can be permanent, even after the drug has been discontinued.

Questor says it plans to begin Phase III of the Emitasol study as soon as possible.

Source: PR Newswire

SOURCE: Reglan Side Effects › Clinical trial underway for metoclopramide nasal spray