Archive for the ‘Therapeutic Classification’ Category

FDA Accepts NDA for Novel Intranasal Sumatriptan to Treat Migraines

Thursday, April 24th, 2014

Exciting news was disseminated from Avanir Pharmaceuticals’ on March 28, 2014 with their announcement that the FDA had accepted a New Drug Application for their intranasal form of Sumatriptan. Designed as a novel and investigational drug-device combination product coined AVP-825, this unique form of Sumatriptan is a breath powered, intranasal form of migraine treatment. The breath powered delivery is an innovative technology in which the user’s breath activates and propels the Sumatriptan dry powder into the nasal cavity. This method of administration is believed to be more effective as once the patient exhales into the device their soft palate automatically closes and seals off the nasal cavity, thus preventing unnecessary inhalation or swallowing of the Sumatriptan powder into their lungs. Once enveloped deep inside the nasal cavity this powder form of Sumatriptan is efficiently absorbed by the body, leading to faster and more effectual relief. This inventive AVP-825 device is constructed to deliver treatment with Sumatriptan on one side of the nasal passages via a nosepiece placed in the nostril. The ability of the nasal passages to expand quickly and rapidly absorb medications makes this new method ideal for fast acting relief for migraine sufferers.

Sumatriptan-CAS-103628-46-2The NDA presented to the FDA for the AVP-825 Sumatriptan device is based on clinical data from a successful Phase II trial. The aforementioned trial, as well as two pharmokinetic studies, included 222 patients who sought treatment for acute migraine headaches. Reference data from two decades of clinical trial research based on the safety and viability of Sumatriptan was also presented in the NDA . With the pathophysiology of migraine headaches still not fully understood, a cure is essential for the estimated 36 million Americans who suffer from migraines. The World Health Organization has placed migraine headaches as one of the 20 most disabling medical illnesses worldwide. While most patients who suffer from these devastating headaches experience between one and four migraines a month, three percent of migraine headache sufferers have chronic migraines. These patients with chronic migraines experience excruciating and disabling headaches for at least fifteen days or more each month, for a period of six months or longer. Migraines are estimated to cost the U.S. over $20 billion every year from missed work, lost productivity, physician visits and medications.

LGM Pharma provides the API Sumatriptan CAS 103628-46-2, 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.

 

Esomeprazole 24 Hour Now OTC

Thursday, April 24th, 2014

The recent FDA approval for AstraZeneca’s Nexium 24 hour, or Esomeprazole, was exciting news for the pharmaceutical world. With over sixty million Americans suffering from heartburn at least once a month the advent of a 24 hour treatment that is easy to access is relieving. As an OTC or over the counter treatment for gastroesophageal reflux disease {GERD} Esomeprazole is effectual at alleviating burdensome symptoms such as pain, excess acid and burning of the esophagus and gastrointestinal tract. Sales of Nexium {Esomeprazole} soared in 2013, reaching $3.9 billion dollars. The recent OTC approval of Esomeprazole by the FDA is poised to generate a sizable profit in 2014.

Esomeprazole-CAS-119141-88-7As an effective medication in the proton pump inhibitor class Esomeprazole works by decreasing the amount of acid created in the stomach. Patients suffering from GERD, Zollinger-Ellison syndrome and ulcers of the stomach due to H. pylori find significant relief when taking Esomeprazole. The newly approved over the counter Esomeprazole stands to aid a greater number of patients and help to remedy the plethora of GERD complications, including chest pain, asthma, bloating, nausea, coughing, dental erosion and hiccups. There are currently a wide array of situational causes for acid reflux, like pregnancy, a hiatal hernia, peptic ulcers, alcoholism, smoking and obesity. With easier access to an OTC remedy patients will be more likely to treat their symptoms of acid reflux with Esomeprazole 24.

Fifteen million Americans report that they have symptoms of GERD, particularly heartburn, every single day. While this debilitating condition affects people of all ages it is most common in adults over the age of forty. Addtionally, the National Digestive Diseases Information Clearinghouse reports that patients with GERD receive over one million prescriptions for medication each year. These patients will not only benefit from Esomeprazole 20 milligrams 24 hour but they will also find an easier path to relief with this newly approved over the counter treatment. The patent for Prilosec I.V., another brand name Esomeprazole product expires in May 2014.

LGM Pharma supplies the API Esomeprazole CAS# 119141-88-7, 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.

 

 

Positive Study Results for Aripiprazole Will Lead to NDA

Friday, April 18th, 2014

Aripiprazole-129722-12-9Alkermes excitedly announced extremely positive study data from a Phase 3 trial of Aripiprazole. This randomized, placebo-controlled and double-blind study gleaned better than expected results, leading pharmaceutical executives at Alkermes to set a plan in motion for an NDA by the third quarter of 2014. As a long acting and injectable antipsychotic treatment Aripiprazole Lauroxil is now available as a once a month dosage in either 441 milligrams or 882 milligrams.

Geared for patients with Schizophrenia, Bipolar Disorder and Major Depressive Disorder Aripiprazole is also known as the brand name Abilify, which is marketed by Bristol-Myers Squibb and Otsuka. Once injected the novel antipsychotic Aripiprazole Lauroxil converts to the molecule Aripiprazole, safely alleviating symptoms of mental illness for roughly one month. The Aripiprazole injectable dose has also proven to be efficacious for sufferers of Bipolar Disorder, as it works to help patients control the highs and lows of manic episodes. Complete Phase 3 study data revealed that not only were primary efficacy endpoints met for the patients who were administered the once a month injection of Aripiprazole, but also this unique form of delivery proved to be as effectual and tolerable as the oral dosage. Side effects from the injectable Aripiprazole were similar to those of the oral form of this drug, and included complaints of mainly headache and fatigue.

Schizophrenia is a severe form of mental illness which affects roughly seven of every thousand adults worldwide, with the vast majority of patients being between the ages of 15 and 35 years of age. One percent of Americans are diagnosed with Schizophrenia and both males and females are affected equally. Schizophrenia occurs across racial boundaries and is currently becoming more commonly diagnosed in children. With WHO estimating 24 million people to have a diagnosis of Schizophrenia worldwide the need for research and development of safe and effective drugs is urgent. The World Health Organization clearly states that Schizophrenia is a treatable condition, but has recently voiced concerns that over half of all patients diagnosed with this serious mental illness do not receive appropriate pharmaceutical care.

LGM Pharma provides the API Aripiprazole CAS# 129722-12-9 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.

 

EU Approves Cabozantinib for Metastatic Medullary Thyroid Carcinoma

Thursday, April 17th, 2014

Cabozantinib CAS# 849217-68-1The end of March 2014 brought exciting news from the EU with the announcement of their approval of Cabozantinib for unresectable medullary thyroid carcinoma. Known as the brand name Cometriq and marketed by Exelixis, Cabozantinib works by inhibiting the activity of MET, RET and VEGFR tyrosine kinases. Cases of medullary thyroid carcinoma are virulent and affect roughly one out of every twenty five patients with thyroid cancer. MTC is considered an uncommon form of thyroid cancer and is believed to be genetic in origin for some patients. Oftentimes medullary thyroid cancer quickly spreads to the lungs, bones and lymph nodes. The National Cancer Institute estimates that a little over 56,000 people will be diagnosed with a form of thyroid cancer this year, and almost 2000 of these patients will not survive their diagnosis. The use of Cabozantinib to treat the patient population with MTC is crucial as this specialty drug is indicated specifically for patients in whom an RET mutation status is negative or unknown. The advent of a treatment opportunity with Cabozantinib offers this group of patients with metastatic MTC new hope.

Cabozantinib (Cometriq) was approved in the United States for the treatment of advanced and unresectable MTC in November 2012. Both the U.S. and the EU based their approvals on positive data from a Phase 3 clinical trial coined EXAM. The EXAM trial was international and multi center and included 330 patients with metastatic medullary thyroid carcinoma. This randomized and double- blinded trial showed that the use of Cabozantinib in patients significantly improved progression-free survival as compared to a placebo. Cabozantinib, as Cometriq, is available in 20 milligram and 80 milligram capsules. The capsules should be swallowed whole on an empty stomach, with a full glass of water. Serious side effects may occur, but many patients found Cabozantinib to be safe and tolerable.

LGM Pharma provides the API Cabozantinib 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.

Trelagliptin Succinate NDA in Japan Captures Global Attention of Pharmaceutical World

Wednesday, April 9th, 2014

Trelagliptin SuccinateRecently, the Trelagliptin Succinate NDA has captured pharmaceutical headlines as it was accepted by the Japanese Ministry of Health, Labour and Welfare. As a unique once weekly treatment for type 2 diabetes, Trelagliptin Succinate is an effectual dipeptidyl peptidase-IV inhibitor. As one of the few providers in the world of Trelagliptin Succinate, LGM Pharma offers this API product for research and development purposes. Takeda Pharmaceuticals, alongside Furiex Pharmaceuticals announced their excitement over a possible marketing of this much needed drug to fight type 2 diabetes in Japan. Trelagliptin Succinate not only offers patients an easy to adhere to treatment for regulating their glucose levels, but it also has proven in a multitude of studies to provide constant and consistent blood sugar control.

The global impact of type 2 diabetes is vast and daunting in nature, with the Worldwide Health Organization predicting type 2 diabetes to be the seventh leading cause of death by the year 2030. India, America and China are currently leading in the number of cases of type 2 diabetes, but other nations are following close behind. Japan, Brazil, Russia, Indonesia, Pakistan and Italy have all shown great increases of patients with type 2 diabetes, and the numbers are not expected to decline.

Clinical trials of Trelagliptin Succinate have proven to be efficacious, with Phase III studies having started in September of 2011. The Phase III trials focused on roughly 600 patients in Japan with type 2 diabetes, and followed these patients for a full year. Trelagliptin clearly offered greater viability as compared to both Sitagliptin Phosphate and a placebo, with the majority of patients who were administered Trelagliptin gleaning a significant decrease in their HbA(1c) levels. Trelagliptin Succinate is also thus far the only “gliptin” that is documented safe in terms of cardiovascular risks.

LGM Pharma supplies the API Trelagliptin Succinate CAS# 1029877-94-8 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.