Archive for the ‘Therapeutic Classification’ Category

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.

EU Approves Apixaban for DVT and PE Treatment and Prevention

Monday, August 25th, 2014

apixabanBristol-Myers Squibb and Pfizer has announced that the European Commission has approved Apixaban (Eliquis) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults.

There is an estimated 600,000 people affected by DVT/PE each year in the U.S., and almost 100,000 of those people die from the terrible condition. A shocking 10 to 30% of those people will die within their first month of diagnosis. Even those who are living with DVT will have long-term complications such as post-thrombotic syndrome, which includes swelling, pain, discoloration, and scaling in the affected limb. Approximately 5 to 8% of the U.S. population has one of several genetic risk factors, also known as inherited thrombophilias in which a genetic defect can be identified that increases the risk for thrombosis.

Deep Vein Thrombosis (DVT)

The marketing authorization for Apixaban follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, and is supported by two pivotal Phase 3 clinical trials, AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) and AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended treatment).

The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway. Apixaban is also approved in the EU for the prevention of venous thromboembolism (VTE) in adults who have undergone elective total hip or knee replacement surgery, and for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors.

“Every year, approximately one million patients in the EU are diagnosed with VTE,” said Dr. Elliott Levy, senior vice president, head of Specialty Development, Bristol-Myers Squibb. “Once a VTE has occurred, approximately 33 percent of patients may experience a recurrence within 10 years.”

“The European Commission’s approval of Eliquis for the treatment of DVT and PE and the prevention of recurrence is an important milestone and demonstrates Bristol-Myers Squibb and Pfizer’s ongoing commitment to bringing innovative medicines to patients who need them,” said Steve Romano, senior vice president, head of Medicines Development Group for Global Innovative Pharmaceuticals, Pfizer Inc.

LGM Pharma is supplier/distributor of the Antithrombotic API Apixaban CAS# 503612-47-3 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.

Amoxicillin Effective When Timed Optimally Before Surgery

Monday, August 18th, 2014

Prophylactic Antibiotics Effective When Timed Optimally Before Surgery

Antibiotics, such as Amoxicillin, are extremely effectual when used appropriately prior to surgical procedures. The expiration of the potent antimicrobial drug Moxatag, also known as Amoxicillin, on October 13, 2020, paves the way for additional development of this generic powerhouse. Study results recently released in Infection Control and Hospital Epidemiology reveal that timing is crucial for the proper use of prophylactic antibiotic treatment. Patients who receive antibiotic prophylaxis approximately two hours before a surgical procedure have a significantly reduced risk of surgical site infections. This data, released by the Rambam Medical Center in Israel on January 15, 2014 indicates that post-surgical patients can absolutely benefit from antibiotic prophylaxis if timed perfectly. Patients who receive antibiotic doses either before the optimal two hour timeframe, or once incisions are made have proven to have notably diminished benefits for infection control.

The aforementioned ten year study in Israel involved 2,537 patients who were in need of preoperative antibiotic prophylaxis, specifically prior to cardiac surgery. Patients involved were given antibiotics at different times, including three hours before surgery, two hours prior to their procedure, one hour before surgery and after surgery was concluded. Data gleaned from this large and randomized study revealed that surgical site infections were least common among the patients who were given antibiotics approximately two hours prior to their surgery. Exactly 8.3 percent of the patient group that received preoperative antibiotic treatment exactly two hours before surgery developed a surgical site infection. This small number of patients is compared with 13.9 percent of patients who developed a surgical site infection, which included patients dosed with prophylactic antibiotics at different times, and not during two hour window prior to surgery. Antibiotics, specifically Amoxicillin are regularly dispensed to patients with heart conditions, such as a heart murmur, prior to both simple and complicated surgical procedures.

LGM Pharma is an Amoxicillin API supplier/distributor for research and development purposes, as well as the sole supplier/distributor of Amoxicillin TEVA API for compounding in 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

Progression Free Survival Goal Met With Cobimetinib

Monday, August 11th, 2014

Vemurafenib and Cobimetinib- a Dynamic Duo in the Fight Against MelanomaImpressive news was revealed from Roche and Exelixis on June 14, 2014 with successful Phase III study results from their melanoma trial. This comprehensive trial involved Exelixis’s Cobimetinib and Zelboraf, which is marketed by Roche, for treating patients with advanced cases of melanoma. All of the 495 patients had specific mutations of the BRAF gene and many were considered to have unresectable cases of this deadly skin cancer. The surprise for clinical trial investigators came when they found the concomitant use of these two drugs led to a longer progression free survival for patients in comparison to their treatment with Zelboraf alone. These top line results are exciting for the medical and pharmaceutical community as this data clears the way for an upcoming FDA application. The Phase III study, coined coBRIM not only met its primary goal of progression free survival, thanks to the addition of Cobimetinib, but it also proved to be safe and tolerable.

Cobimetinib is a highly selective inhibitor of mitogen-activated protein kinase MEK, and has demonstrated efficacious ability sustain the inhibition of MEK in both mutant RAS and BRAF tumor models. The development of Cobimetinib is currently under Roche and Genentech, with a collaboration agreement with Exelixis. A successful Phase 1b dose escalation study of Cobimetinib, called BRIM7, proved this potent drug was effectual when used adjunctively with the BRAF inhibitor Vemurafenib. The BRIM7 study involved patients with metastatic cases of melanoma who had the BRAFV600 mutation, with the results being presented at the 10th European Association of Dermato-Oncology Congress in May 2014.

Clinical trials are ongoing for Cobimetinib alongside other anti-cancer agents, and many of the patients accepted in these trials are chosen specifically for their genetic mutations. Current studies include combining Cobimetinib with: GDC-0068, an AKT inhibitor; Onartuzumab, a MET targeting antibody; MEHD7945A, a biotherapeutic targeting EGFR and HER3; and GDC-0941, a PI3K inhibitor. This patient population is facing a critical need for new and innovative treatment, and Cobimetinib looks like it may be the agent to meet this need.

LGM Pharma is a provider of the API Cobimetinib, CAS # 934660-93-2 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.