Archive for the ‘Therapeutic Classification’ Category

Vilanterol Remains a Steadfast Opponent for COPD

Thursday, April 23rd, 2015

vilanterolAs a virulent lung disease that is believed to be caused by both smoking and air pollution, COPD, or Chronic Obstructive Pulmonary Disease, is a serious health threat. In the United States COPD is deemed the third leading cause of death as of 2015, with roughly 600 million people worldwide suffering from this debilitating disease. Characterized by chronic airway inflammation and a progressive loss of lung function, COPD now accounts for fifty billion dollars in treatment costs for the U.S. alone. The severe exacerbations that the majority of patients with COPD suffer from cause a plethora of adverse effects, ranging from breathlessness to difficulty performing any tasks requiring physical exertion. People enduring severe exacerbations on a regular basis are almost forty percent likely to die within a year from these events, and two-thirds of these patients will perish within three years’ time. The need for both novel and continuous treatment options is great, and Vilanterol has continued to fill this need for many years.

Known as an integral part of the brand name inhaler Breo Ellipta, Vilanterol works in tandem with Fluticasone Furoate as an effectual long-acting beta2-adrenergic agonist. Marketed by GlaxoSmithKline and Theravance, Breo Ellipta is FDA approved to treat adults with COPD. Vilanterol and Fluticasone Furoate have proven to be a dynamic duo for reducing exacerbations in patients with COPD, and aiding patients with airflow obstruction issues. The use of this once a day inhaled therapy is ideal for a safe and tolerable long term treatment option. Breo Ellipta is actually the first FDA-approved inhaled therapy to be used once daily for COPD patients that contains both a corticosteroid and long-acting beta2-adrenergic agonist. Adverse events in clinical trials and post market studies have been rare, with common side effects noted being oral candidiasis and mild nasal irritation.

The ability of Vilanterol to contribute to 24 hour control, alongside Fluticasone Furoate, makes this combination a novel and viable treatment for COPD patients. With almost 13 million Americans currently diagnosed with this devastating disease COPD has become an emerging condition which research and development teams are seeking to find treatments for. LGM Pharma can assist clients as a supplier/distributor of the API Vilanterol, CAS # 503070-58-4 and also 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.

 

FDA Approves Olopatadine Hydrochloride for Ocular Itching

Monday, April 20th, 2015

FDA Approves Olopatadine for Ocular ItchingOn February 3, 2015 the FDA approved Olopatadine Hydrochloride, ophthalmic solution 0.7%, for the treatment of ocular itching due to allergic conjunctivitis. Known as the brand name Pazeo, which is marketed by Alcon, the approved dose is one drop in each affected eye daily. Positive data from two trials coined Conjunctival Allergen Challenge demonstrated that significant relief from ocular itching was found after just 24 hours. When compared to the Olopatadine drop 0.2%, or the brand name Pataday, the 0.7% drop proved efficacy after a shorter time period. Adverse effects were extremely uncommon, with a minor number of patients reporting dry eye or slight blurriness. The option for effective and swift relief for patients suffering from severe itching due to allergic conjunctivitis is encouraging news for this sizable patient population. Pazeo solution will become available by prescription starting in March 2015.

Allergies are prevalent in the United States, with approximately one third of people affected by seasonal allergy symptoms. A staggering 75 percent of these allergy sufferers endure minor to intense ocular itching as a result of allergic conjunctivitis. Olopatadine has proven safe for patients who wear contact lenses, although it is advised that at least five minutes pass after administration of the drop before lenses are placed in the eyes. Symptoms of allergic conjunctivitis include:

  • Extreme itching and/or burning eyes
  • Red eyes
  • Puffy eyelids, particularly in the morning
  • Excessive tearing
  • Dilated blood vessels in the clear tissue that covers the whites of the eyes

LGM Pharma can assist clients as a supplier/distributor of the API Olopatadine Hydrochloride, CAS# 140462-76-6 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 Agrees to Priority Review of Sumatriptan and Naproxen Sodium for Adolescent Patients

Wednesday, April 15th, 2015

Sumatriptan and Naproxen SodiumOn January 15, 2015 Pernix Therapeutics excitedly announced an FDA acceptance for a priority review of Sumatriptan and Naproxen Sodium, also known as Treximet, for adolescent patients. Pernix expects an FDA approval by the second quarter of 2015, which would greatly benefit the adolescent patient population suffering from migraines. This anticipated approval would be specific to adolescents between the ages of 12 and 17, for the treatment of migraine headaches both with and without aura. Data from three comprehensive trials was given to the FDA, proving the efficacy, safety and tolerability of this formidable therapy. Currently there is no approved treatment for the adolescent population that includes Sumatriptan, either alone or in combination with another drug. The Sumatriptan/Naproxen Sodium combination is only approved for use in adults for the acute treatment of migraine headaches, with and without aura. The approval of Treximet for the adolescent population would grant a remedy to a patient population in need of novel treatments to combat debilitating migraines.

The incidence of migraines has become greater among both children and adolescents over the past decade. A startling 82 percent of children report having experienced a migraine-like headache by age 15, and 6 percent of American adolescents are documented to be suffering from migraines on a yearly basis. Migraine headaches can affect children and adolescents similarly to adults, and they can be just as disabling. However, studies have shown that the duration of migraines tends to be a bit shorter in adolescents as compared to their adult counterparts, with many young people experiencing a migraine attack lasting about an hour. The range of the disabling symptoms of a migraine headache have been between 1 and 72 hours for the majority of adolescents. Additionally, the adolescent patient population experiences mainly frontal or temporal pain, unlike adult sufferers who typically endure unilateral pain.

LGM Pharma can assist clients as a supplier/distributor of the APIs Sumatriptan and Naproxen 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.

Micafungin Remains a Viable Treatment for Candida Infections

Wednesday, April 8th, 2015

Micafungin CAS 235114-32-6As the fourth most common cause of hospital-acquired bloodstream infections in the United States, Invasive Candidiasis is a concern for any patient battling a fungal infection. Micafungin, also known as the brand name Mycamine, which is marketed by Astellas, is an effective antifungal agent. By inhibiting the synthesis of 1,3-beta-D-glucan, Micafungin proves to be a viable member of the echinocandin class of antifungaI therapies. Micafungin is classified as an antiinfective, antibiotic and antifungal drug. Concerns by medical professional worldwide for a rising number of systemic fungal infections over the past two decades are prevalent, with an increasing urgency for continued R&D to meet the needs of tomorrow’s patients. While the candida species are most commonly found in patients who are immunocompromised, the Candida organism is responsible for an overwhelming 80 percent of all major systemic fungal infections.

Micafungin is an approved treatment for patients with esophageal candidiasis, as well as for the prophylaxis of Candida infections in patients who are undergoing hematopoietic stem cell transplantations. Micafungin is determined to be effectual for treating the susceptible organisms C. tropicalis, C. albicans, C. glabrata, C. krusei, C. parapsilosis, and C. krusei. Off-label treatment with Micafungin is also used for patients with pulmonary Aspergillus infection. Micafungin is a successful therapy for treating and preventing a wide variety of fungal infections, with few adverse effects occurring. A minor number of patients experience injection site irritation, diarrhea, vomiting and headache.

As an injectable medication Micafungin is administered via an intravenous solution, typically given once daily for a set period of time. The injection is administered slowly, over at least a one hour period. Patients with Candidiasis usually receive a daily dose based on weight for between ten and thirty days’ time. Patients who are administered Micafungin as a prophylaxis prior to a hematopoietic stem cell transfer will typically receive 50 milligrams daily for between six and fifty days. Those patients who are diagnosed with Candidemia, Candida Peritonitis and Abscesses or Disseminated Candidiasis will likely be administered 100 milligrams daily for between ten and forty-seven days.

Clinical trials of Micafungin have proven to be valuable and successful. In June 2013 the FDA approved Micafungin, as Mycamine, for the treatment of fungal infections in pediatric patients ages four months and older. With Candida infections being a serious concern for the pediatric patient population due to limited treatment options, this approval was welcomed by the medical and pharmaceutical community. Two double-blind and randomized trials of Micafungin (Mycamine) demonstrated the safety and tolerability for pediatric patients who received this antifungal therapy for either the treatment of invasive Candidiasis and Candidemia or the prophylaxis of Candida infections. Of the 479 patients assessed, ages three days through 16 years old, the average once daily treatment regimen was 24.8 days. Every patient received at least one dosage of Micafungin. The most commonly reported adverse effects was vomiting, followed by diarrhea. The FDA did not evaluate or approve the use of Micafungin in patients younger than 4 months old, however.

LGM Pharma can assist clients as a supplier/distributor of the API Micafungin, CAS # 235114-32-6 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.

Canagliflozin Continues to be a Viable Treatment for Type 2 Diabetes

Monday, April 6th, 2015

hemoglobin a1cOn January 16, 2015 the Journal of Diabetes and its Complications shared positive findings from a recent post hoc analysis of Canagliflozin. Comprehensive data was analyzed from Phase 3 studies of Canagliflozin in adult patients with type 2 diabetes. This placebo-controlled study was comprised of four 26 week periods, with changes in HbA1c being sought by the end of each 26 week segment. Canagliflozin proved to be successful in lowering the HbA1c of the participants as well as showing overall glycemic improvements. Dosages of 100 milligrams and 300 milligrams of Canagliflozin elicited significantly greater reductions in HbA1c as compared to the patients who were administered a placebo. Additionally, patients tolerated Canagliflozin well and the safety profile of this anti diabetic therapy was tangible. As an effectual sodium glucose co–transporter 2 inhibitor Canagliflozin has performed remarkably in a vast number of studies over the last decade.

Another recent article focused on the positive effects of Canagliflozin, published in the January 20, 2015 issue of Diabetes, Obesity & Metabolism. The information disseminated revealed a sizable reduction on serum uric acid in patients with type 2 diabetes mellitus who were given Canagliflozin in studies. An increase in uric acid, also known as Hyperuricaemia can often lead to complications from type 2 diabetes, such as kidney stones and gout. Information gleaned from four Phase 3 studies showed a reduction of 13 percent on serum uric acid levels for patients who were administered Canagliflozin, as compared to a placebo. The reduction was apparent at week 26 of the studies on average, and patients who saw these reductions also experienced a major decrease of incidences with gout and kidney stones. Of the patients who received 100 milligrams of Canagliflozin 23.5 percent of these participants saw a viable reduction in serum uric acid levels. Approximately 32.4 percent of participants who were dosed with 300 milligrams daily of Canagliflozin experienced a worthy reduction in serum uric acid levels. Patients in the placebo group had a mere 3.1 percent reduction in their uric acid levels at the 26 week mark.

canagliflozinKnown as the brand name Invokana, which is marketing by Janssen, Canagliflozin is an oral medication used to treat type 2 diabetes. Patients with type 1, or juvenile diabetes, should not take Canagliflozin. In addition to diet and exercise Canagliflozin has shown to be a safe and effective treatment for adult patients with type 2 diabetes who cannot control their glucose levels. Canagliflozin is typically taken once daily by mouth. Adverse effects are uncommon, with most commonly reported side effects being nausea, constipation and frequent urination. LGM Pharma can assist clients as a supplier/distributor of the API Canagliflozin, CAS # 842133-18-0, 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.