Archive for the ‘Therapeutic Classification’ Category

Tavaborole Approved as Antifungal Toenail Treatment

Monday, October 20th, 2014

Tavaborole CAS 174671-46-6 Onychomycosis TreatmentAnacor Pharmaceuticals, Inc. ANAC, announced on Jul 08, 2014 that the FDA has approved the New Drug Application for Tavaborole, which is marketed as KERYDIN™ topical solution, 5%. Tavaborole was designed to be convenient for patients to use and it’s the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails.

Onychomycosis is a progressive, recurring fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today.

Tavaborole is a broad-spectrum oxaborole antifungal agent with low molecular weight, permitting optimal nail plate penetration. Tavaborole is a clear, colorless, alcohol-based solution applied with a dropper to the infected toenail once daily for 48 weeks. Debridement of the nail is not required during the treatment period. Due to its topical application, KERYDIN has low systemic absorption and has not demonstrated systemic side effects.

Studies have demonstrated the superior nail-penetrating properties of tavaborole compared to existing topical antifungal medications approved for the treatment of onychomycosis.

Onychomycosis is one of the most common diseases diagnosed causing approximately one-half of all nail disorders, and it’s prevalence has been steadily increasing. It is difficult to treat, partly due to the subungual location and the inability of both oral and topical antifungals to reach the site of infection. Historically, a large number of patients with onychomycosis would choose not to treat their infection. With the approval of Tavaborole, physicians can now offer patients a safe, effective and easy-to-use topical treatment for their onychomycosis of the toenail.

LGM Pharma can assist clients as a supplier/distributor of Tavaborole CAS No: 174671-46-6, 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.

Idelalisib EU Approval Granted For Treating CLL and FL Patients

Wednesday, September 24th, 2014

Idelalisib CAS 870281-82-6Gilead Sciences has been granted marketing authorization by the European Commission for its Idelalisib 150mg tablets (to be marketed as Zydelig) to treat the two incurable blood cancers Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma (FL). This formidable first-in-class oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, plays a key role in the activation, proliferation and viability of B cells, a critical component of the immune system.

The EU indications are similar, but not identical, to those in the U.S., where Idelalisib was approved in July 2014. For the treatment of CLL, the Idelalisib EU approval covers the use of Idelalisib combined with Rituximab for patients who have received at least one prior therapy (same as the US indication).

chronic lymphocytic leukemia (CLL)This Idelalisib EU approval was based mainly on a trial in 220 patients that was stopped early after it showed a significantly longer progression-free survival in patients receiving Idelalisib plus Rituximab. The results were published earlier this year in the New England Journal of Medicine. Researchers concluded that the addition of Idelalisib to Rituximab “provided effective durable disease control and improved overall survival for patients with relapsed CLL who were not suitable for cytotoxic chemotherapy, including high-risk patients.” Researchers also mentioned that treatment for CLL can be worse than the disease, leading to a great deal of side effects and death.

Idelalisib will be administered along with Rituximab for patients fighting refractory CLL. While there is a slight risk of serious toxicities, the majority of patients had common adverse reactions that were not deemed severe, and included pyrexia, abdominal pain, diarrhea, nausea and a mild rash. These adverse effects were seen in patients who were administered Idelalisib both with and without the addition of Rituximab.

Idelalisib is also EU approved to treat Follicular Lymphoma (FL) as monotherapy in patients who are refractory to two prior lines of treatment. This approval is supported by positive data from a phase 2 study of Idelalisib monotherapy in 125 patients.

The researchers concluded that Idelalisib “appears to provide effective oral monotherapy in patients with previously treated indolent non–Hodgkin’s lymphoma,” and these data were described as “eyebrow raising” when they were first presented at the 2103 American Society of Hematology meeting.

The advent of Idelalisib offers patients with these hard to treat forms of blood cancers better options for treatment and hope for tangible progression free survival. Idelalisib is also easy to administer as oral tablets which are typically taken twice daily, either with or without food. There are over 200,000 patients in the United States who suffer from relapsed follicular B-cell non-Hodgkin lymphoma, relapsed chronic lymphocytic leukemia or small lymphocytic lymphoma. This patient population is clearly in need of innovative and effective treatments.

LGM Pharma can assist clients as a supplier/distributor of Idelalisib, CAS # 870281-82-6, 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.

FDA Approves Contrave – A Naltrexone Hydrochloride and Bupropion Hydrochloride Drug Combo

Friday, September 12th, 2014

Bupropion NaltrexoneOn September 10, 2014, The U.S. Food and Drug Administration (US FDA) approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) for anti-obesity treatments in combination with a reduced-calorie diet and exercise. Contrave is distributed by Takeda Pharmaceuticals America Inc. of Deerfield, Illinois for Orexigen Therapeutics, Inc. of La Jolla, California.

The FDA approved the naltrexone hydrochloride and bupropion hydrochloride drug combo for use by people with a body mass index of 30 or higher. It is also approved for use by people with a BMI of 27 or higher who also have a weight-related medical condition such as high blood pressure (hypertension), diabetes, or high cholesterol (dyslipidemia).

The naltrexone and bupropion drug combo are already approved for alcohol and narcotic dependence. In addition, naltrexone has already been approved for treating alcohol and narcotic dependence, and bupropion has already been approved as an antidepressant to help people quit smoking.

obesity in america In addition to Contrave, the FDA has approved 2 other drugs for anti-obesity treatments, including Qsymia from Vivus Inc. and Belviq from Arena Pharmaceuticals Inc. Sales of the drugs, once considered potential billion-dollar sellers, have been below expectations because of limited insurance coverage and high costs for patients.

In experiments, non-diabetic patients lost 4.1 percent more weight than patients who took a fake pill.

The drug will have a boxed warning about the risk of suicidal thoughts associated with antidepressants like Bupropion. Additional risks include the possibility of seizures, as well as increased blood pressure and heart rates.

The heart effects created a long road to approval for Contrave. The FDA refused to approve the drug in 2011, citing cardiovascular risks. Orexigen resubmitted its application to regulators in December, saying that the drug fared well in an early analysis of a study designed to rule out excessive cardiovascular risk.

Contrave will be distributed in the U.S. by Japanese drugmaker Takeda Pharmaceuticals, which will pay Orexigen royalties on sales. Orexigen and Takeda plan to start selling the drug in the fall of 2014.

 

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.

Aripiprazole Lauroxil NDA Submitted to Treat Schizophrenia

Tuesday, September 2nd, 2014

The Brain in SchizophreniaThe USFDA has received the Aripiprazole Lauroxil NDA, submitted by Ireland-based Alkermes for treating patients with schizophrenia. Alkermes shares gained almost 2.3% on the news.

Aripiprazole lauroxil is a partial dopamine agonist of the second generation class of antipsychotics, with one-month and two-month formulations, developed for the treatment of the mental disorder schizophrenia, which is a chronic, severe and disabling brain disorder.

Alkermes has submitted the NDA based on results from the successful randomized, multicenter, double-blind, placebo-controlled, phase III trial which assessed the efficacy and safety of aripiprazole lauroxil, where the drug demonstrated significant improvements in schizophrenia symptoms when compared to a placebo.

“We have designed aripiprazole lauroxil to be a differentiated treatment option for schizophrenia, with a ready-to-use format with multiple dosing options.”

Alkermes CEO Richard Pops said: “We have designed aripiprazole lauroxil to be a differentiated treatment option for schizophrenia, with a ready-to-use format with multiple dosing options, to help meet the individual needs of patients and their healthcare providers.

“These attributes, together with the robust clinical data observed in the pivotal study, position aripiprazole lauroxil to be a meaningful new entrant in the growing long-acting injectable antipsychotic market, and we look forward to working with the FDA to bring this important new medication to patients and physicians as quickly as possible.”

The completion of the Phase III study, in which both doses of aripiprazole lauroxil tested, 441mg and 882mg administered once monthly, reached the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo.

Aripiprazole lauroxil was generally well tolerated in the study, and the observed safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache.

LGM Pharma is supplier/distributor of the API Aripiprazole CAS 129722-12-9 for research and development purposes, as well as the Aripiprazole (TEVA API) for compounding purposes within the U.S.. 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.

FDA Approves Fluticasone Furoate for Once-Daily Asthma Therapy

Wednesday, August 27th, 2014

GlaxoSmithKline has announced that the FDA has approved fluticasone furoate inhalation powder, as a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as preventative therapy in patients 12 and up. This therapy is only intended to prevent an asthma attack, not to treat it once it happens. For treating an asthma attack, one would still need a rescue inhaler.

Fluticasone Furoate CAS No: 397864-44-7

The approved doses of the fluticasone furoate inhalation powder, marketed as Arnuity Ellipta, are 100mcg and 200mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio.

Last year, the FDA approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.

The market for asthma drugs is predicted to reach $18 billion by 2021, according to new research. With six products forecast to launch, the research estimates the asthma market in the USA, Japan, and five major European Union markets (France, Germany, Italy, Spain and the UK), will grow at a rate of 1.4% by 2021.

Asthma Drug TherapyDarrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, “The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the US and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients.”

The efficacy and safety of Arnuity Ellipta have been evaluated in more than 3,600 patients with asthma. The most common side effects (reported in at least 5% of people) were upper respiratory tract infection, common cold, headache, and bronchitis. Side effects are similar to those of other inhaled steroids. For example, some people may develop a yeast infection in their mouth. Those with a severe milk allergy should not use this drug. Close monitoring for glaucoma and cataracts is also needed, the company says.

LGM Pharma is supplier/distributor of the API fluticasone furoate Fluticasone Furoate CAS 397864-44-7 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.