Archive for the ‘Therapeutic Classification’ Category

New Guidelines Highlight Divalproex Sodium as an Effective Migraine Treatment

Monday, May 20th, 2013

neurology-articleThe latest news regarding divalproex sodium is exciting for patients who suffer from migraine headaches. A new set of guidelines were published in the April 24, 2012 issue of Neurology, and presented at the academy’s annual meeting in New Orleans April 21 to 28, 2013.  The new guidelines are composed of information from 29 studies that were published between 1999 and 2009. These studies describe effectual preventive treatments for migraine headaches. Among the vast array of prescription drugs evaluated, divalproex sodium was clearly shown to reduce the number of migraine attacks, as well as the severity of them for patients. The information that divalproex sodium, as well as several other anti-epileptic medications, can reduce the amount of migraine headaches by up to fifty percent was encouraging for patients, practitioners and research and development teams.

Divalproex Sodium CAS No: 76584-70-8Divalproex Sodium, CAS# 76584-70-8, is also known as the brand name Depakote ER. With the patent for Abbott’s pivotal treatment set to expire on December 18, 2018, researchers are taking another look at this powerhouse product. Divalproex sodium is approved to treat various types of seizure disorders. This medication helps with seizures by affecting the chemicals and nerves in the body that can cause the seizure activity. Divalproex Sodium is recommended as a stand-alone treatment or in combination with other anti-epileptic medications for adults. Children ages 10 and older are typically prescribed divalproex sodium to treat complex partial seizures. Patients with liver disease or a urea cycle disorder should not take this medication. Pancreatitis is a rare, but potential adverse effect of this medication. Common side effects include constipation, hair loss, tremors and upset stomach.

migraineThere are more than 37 million Americans who suffer from migraines and approximately 3.2 million Americans have chronic migraine, which is defined as migraine or tension-type headaches 15 or more days a month.  Statistics from the World Health Organization reveal that migraine headaches are responsible for at least 1% of the total U.S. medical disability burden.

LGM Pharma provides Divalproex Sodium for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Profitable Sitagliptin is a Best Selling Pharmaceutical Product

Monday, May 13th, 2013

SitagliptinThe patent for the phenomenal Sitagliptin, known as the brand name Januvia, is set to expire on April 24, 2017. As a blockbuster drug sitagliptin, CAS number 486460-32-6, is set up for undoubted success as a generic drug. Sales of Januvia in both the United States and Japan are extremely strong, so much so that Merck’s best-selling pharmaceutical product is Januvia. Results from 2012 financials revealed Januvia enjoyed a 23 percent year-to-year sales boost, to almost $4.1 billion in the 2012 calendar year. The fourth quarter sales of Januvia climbed 18 percent, to $1.1 billion dollars, as compared to $960 million dollars in the last quarter of 2011.

HypoglycemiaAs a medication designed to help patients with type 2 diabetes control their blood sugar levels, sitagliptin works by regulating insulin levels of patients. Sitagliptin is offered as Januvia is dosages of 25 milligrams, 50 milligrams and 100 milligram tablets. With almost 95 percent of the diabetic patients in the United States diagnosed with type 2 diabetes, roughly one out of ten American adults has the treatable and controllable form of this disease. The future picture of type 2 diabetes in the U.S. is not reassuring either, as predicted by the Centers for Disease Control, or CDC.  The CDC estimates that by 2050 a staggering one out of every three adults in the United States may be suffering from diabetes, based on current medical trends. These future diagnoses will strain not only the  American healthcare system, but also the pharmaceutical industry.

Encouraging data was presented at the 61st Annual Scientific Meeting of the Gerontological Society of America, showcasing the success of Januvia, or sitagliptin, in studies completed among patients in the elderly population.  Merck  sponsored the aforementioned study, which focused on elderly patients who had type 2 diabetes. The patients who participated in this 24-week double-blind  and randomized study involved roughly 206 patients between the ages of  65 and 96.  The patients who were dosed with sitagliptin showed dramatic reductions in their blood sugar levels, without hypoglycemic symptoms.

LGM Pharma provides API sitagliptin for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

New Trial Initiated for Linagliptin and Patients with Type 2 Diabetes

Wednesday, May 8th, 2013

linagliptinEli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc. announced on March 19, 2013 the initiation of a novel clinical trial for linagliptin. Coined MARLINA, this Phase IIIb trial will evaluate the glycemic efficacy and safety of linagliptin in patients with type 2 diabetes who have prevalent albuminuria. This patient population, suffering from albuminuria, will be evaluated while continuing to remain on standard therapy for the treatment of diabetic nephropathy. Researchers have determined that in diabetic patients with a type 2 diagnosis have elevated levels of blood glucose which can damage the filters of their kidneys. This damage often leaves these type 2 patients at a high risk for developing  renal impairment. Albumin leakage is one of the first signs of early –stage renal disease and kidney damage, making this study extremely pertinent for this patient group.  The goal of this study is to document a change from the baseline HbA1c of patients after roughly six months of treatment. This study is slated to be completed in 2014.

Linagliptin has been in the pharmaceutical spotlight within the past year, tagged as being an effectual API to combat type 2 diabetes – previous Linagliptin news.

American Association of Clinical EndocrinologistsA retrospective analysis of linagliptin data was presented on May 6, 2013 at the AACE 22nd Annual Scientific & Clinical Congress. The data analysis and presentation focused on specific subsets of patients, specifically the Hispanic and Latino groups. All of the patients documented in the presentation had type 2 diabetes for ten years or longer. The use of linagliptin showed marked improvement in blood sugar levels for all of the patient subsets across the studies and data compiled. Type 2 diabetes has become a worldwide problem and accounts for 90% – 95% of all diabetes cases, which creates a global need for effective and safe treatment options until a cure is found. The patent for Tradjenta {linagliptin} expires on April 24, 2017.

Linagliptin, CAS# 668270-12-0, is available from LGM Pharma for research and development purposes. Clients can be assured of complete support throughout the entire R&D process, as well as quality API products.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Tadalafil Makes Headlines at the European Association of Urology Congress

Monday, May 6th, 2013

European Association of Urology CongressTadalafil, also known as Cialis, is making headlines in pharmaceutical news. A study released on March 18, 2013 touted the use of tadalafil {Cialis} alongside finasteride for sizably improving scores for men on the International Prostate Symptom Score. Marketed by Eli Lilly, the patent for Cialis expires on November 21, 2017. The study, which was revealed at the European Association of Urology Congress in Milan, showed that five milligrams of tadalafil {Cialis} administered alongside finasteride once daily significantly improved the scores for men on the International Prostate Symptom Score. These men had lower urinary tract symptoms of benign prostatic hyperplasia and enlarged prostates. Additionally, the co-administration of tadalafil and finasteride improved the erectile function scores in these men, who had both lower urinary tract symptoms of benign prostatic hyperplasia and erectile dysfunction at baseline. Both studies compared the once daily use of tadalafil and finasteride to finasteride and a placebo.

Currently approved by the FDA to treat the signs and symptoms of both benign prostatic hyperplasia and erectile dysfunction, tadalafil is proving to be successful. Finasteride is currently approved by the FDA for the treatment of men with benign prostatic hyperplasia with an enlarged prostate. The aforementioned study was comprehensive, and involved 696 men ages 45 and older. All of the men had an International Prostate Symptom Score of at least 13, a urine flow rate of 4 millimeters per second to 15 mL/sec and a prostate volume at least 30 mL. Results revealed that the primary endpoint was met regarding improved International Prostate Symptom Scores {IPSS}. The IPSS scores showed meaningful improvements through the 12 week study. The scores at 12 weeks significantly improved IPSS scores, specifically -5.2 for the tadalafil and finasteride group versus the placebo/finasteride at -3.8. The daily dose of tadalafil and finasteride also greatly improved the men’s IPSS total scores versus the placebo/finasteride at 4 weeks, specifically -3.9 versus -2.3. Finally, the 26 week mark also rendered a cogent result, with IPSS total scores of the tadalafil and finasteride treatment versus the placebo/finasteride being -5.5 versus -4.5.  With mild side effects such as headache, indigestion and back pain, results from this study appear to show the tadalafil and finasteride drug combination to be safe, efficacious and generally tolerable. LGM Pharma provides TEVA API tadalafil, CAS number 171596-29-5, as well as finasteride, CAS number 98319-26-7 for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Daclatasvir and Asunaprevir are a Promising Oral Treatment for Patients with the Hepatitis C Virus

Monday, April 29th, 2013

The Hepatitis C virus is daunting in nature, affecting 180 million people worldwide and a little over 4 million people in the United States. As the leading cause of chronic liver disease, which often leads to liver cancer, hepatitis C is currently difficult to treat with success. The typical treatment for patients with hepatitis C today involves injections of the antiviral drug interferon alpha. This standard treatment is generally not well tolerated by patients, leading to a discontinuation of treatment altogether. Adverse effects of the interferon alpha injections include fevers, flu symptoms, exhaustion, weakness and depression.

treatment with the daclatasvir and asunaprevirHCV RNA Levels in Groups A and B after treatment with the daclatasvir and asunaprevir

There is a new hope, however, for these millions of patients, in the form of a new drug combination treatment. On April 25, 2013 Bristol Myers revealed the success of a novel oral hepatitis C cocktail. This drug combination is made up of Daclatasvir, CAS number 1009119-64-5 and Asunaprevir, CAS number 630420-16-5. The oral administration of this medication is significant, as it eliminates the need for painful and side effect laden injections. In addition, this two punch combo has been proven to successfully clear the hepatitis C virus in patients who had not previously responded to the standard injection treatments.

One study, published in The New England Journal of Medicine in January 2012 focused on an arm of patients who were infected with the most common type of the hepatitis C virus- genotype 1. These patients had not responded to prior treatments of interferon and ribavirin. However, after treatment with the daclatasvir and asunaprevir duo, the patients showed a 90% to 100% rate of sustained response. Patients documented mild side effects of diarrhea, nausea, headache and fatigue.

While the dynamic combination of daclatasvir and asunaprevir is not yet FDA approved, scientists are hopeful that this oral regimen will be ready to go by 2015.

LGM Pharma provides both daclatasvir and asunaprevir for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.