Archive for the ‘Therapeutic Classification’ Category

Paliperidone Approved as Quarterly Therapy for Patients with Schizophrenia

Friday, August 21st, 2015

Paliperidone Palmitate Approved as Quarterly Therapy for Patients with SchizophreniaThe FDA gave the green light in late May 2015 with their approval of a quarterly dosing schedule of Paliperidone Palmitate, also known as Invega Trinza. Marketed by Janssen Pharmaceuticals this novel dosing regimen is the first ever quarterly dosing therapy for patients with Schizophrenia. Paliperidone is dispensed to patients via an intramuscular injection every three months, offering patients freedom from daily medications. This novel administration not only helps to insure patient’s medication adherence, but it also takes the stress of remembering daily, weekly and monthly medications away. The only prerequisite for patients seeking to take this medication is an adequate, once a month therapy with Invega Sustenna for at least four months prior to beginning Invega Trinza (Paliperidone).

A comprehensive phase III maintenance trial determined the efficacy and safety of the Paliperidone three-month formula, comparing it with a placebo in regard to delaying the time gleaned before a relapse of schizophrenic symptoms returned. This randomized study included a three-week screening phase; a lengthy seventeen-week flexible dosing phase; an open-label transition phase; a double-blind phase which was open ended and a twelve-week open-label maintenance phase. Approximately 305 patients between the ages of 19 and 70 years of age participated in this successful study. The patients were assigned at random to receive either three months of Paliperidone Palmitate or a placebo, via injection. The group of patients who were administered the Paliperidone showed a distinct advantage in terms of time until a relapse of symptoms, as compared to the patients who received the placebo. A staggering 93 percent of patients who were dosed with Paliperidone (Invega Trinza) did not experience a significant return of schizophrenia symptoms while on the three-month dosage. There were some reports of minor side effects, such as akathisia, headache and slight weight gain.

As a chronic and very severe brain disorder Schizophrenia occurs in about one percent of the U.S. population. More than 21 million people around the globe suffer from Schizophrenia. Manifestation of Schizophrenia and the first “episode” is usually around 21 years of age for males and about 27 years of age for females. Men far outnumber the patient population with a Schizophrenia diagnosis by age 30. The good news is that this potentially debilitating condition is treatable with accurate diagnosis and proper medication and care.

LGM Pharma can assist clients as a supplier/distributor of the API Paliperidone, CAS #144598-75-4 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.

Increased Bone Mineral Density in Denosumab Data Presented at ENDO 2015

Monday, August 17th, 2015

ENDO wrist denosumabExciting news was presented at ENDO 2015 regarding the use of Denosumab for osteoporosis in post-menopausal women who are at high risk for bone fractures. Results from a comprehensive trial coined Freedom showed the use of Denosumab successfully increased bone mineral density (BMD) at cortical bone sites, particularly the 1/3 radius skeletal site which does not typically respond to osteoporosis treatments. The Freedom trial was documented during 3 years of placebo/Denosumab administration and another 6 years of treatment for patients with Denosumab only. The incidence of wrist fracture and 1/3 radius BMD were examined in 2,207 women. The extended 6 years of data gleaned was deemed the Freedom Extension trial. Of the 2,207 women, all with varying degrees of wrist fracture, not one woman withdrew from the trial due to adverse effects. The female participants also received daily doses of both vitamin D and calcium in addition to either the placebo or Denosumab doses. The participants in the Freedom Extension trial experienced bone loss reversal, which resulted in bone mineral density gains at the 1/3 radius of 1.5 percent. An overwhelmingly positive conclusion was drawn by study investigators that treatment with Denosumab for at least 3 years was able to not only stop, but also reverse bone loss. Additionally, greater than 3 years of Denosumab therapy translated into both gains in BMD as well as lower wrist fracture rates in the future overall. Reversing the cortical bone loss in patients suffering from osteoporosis is key in the prevention of fractures and injuries for this susceptible patient population.

Age and bone massDenosumab, also known as the brand name Prolia, which is marketed by Amgen, is prescribed for women and men at risk for osteoporosis, although the majority of patients using Denosumab therapy are females who are postmenopausal. This drug is in the classification of monoclonal antibodies and there are few adverse effects associated with Denosumab. Commonly reported side effects include constipation, muscle pain and muscle weakness. The typical dosage of Denosumab is 60 milligrams, administered via one subcutaneous injection approximately every 6 months. Patients who are undergoing therapy with Denosumab are usually advised to take 1000 milligrams of calcium daily, as well as 400 IU of vitamin D daily. In addition to women who are at risk of osteoporosis due to menopause Denosumab is also prescribed for the following:

  • Postmenopausal women who are at high risk for fractures, specifically in need of a reduction in risk for vertebral and hip fractures.
  • Women who are at menopause or are postmenopausal and cannot tolerate other forms of treatment for the prevention of osteoporosis.
  • Therapy for women who are at risk of bone loss due to breast cancer therapy with aromatase inhibitors.
  • As a treatment for men who are at risk for osteoporotic bone fractures due to a current diagnosis of osteoporosis or who are at a very high risk of getting osteoporosis.
  • Treating men who have bone loss due to androgen deprivation therapy, as a result of nonmetastatic prostate cancer treatments.

LGM Pharma can assist clients as a supplier/distributor of the API Denosumab, CAS # 615258-40-7 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.

 

Gemcitabine and Cisplatin Continue as Successful Therapy for Patients with NSCLC

Tuesday, August 11th, 2015

Gemcitabine and Cisplatin

Patients with non-small cell lung cancer, also known as NSCLC, are anxiously awaiting a decision from the FDA’s Oncologic Drugs Advisory Committee regarding Eli Lilly’s introduction of Necitumumab to the already formidable Gemcitabine and Cisplatin combination. Both Gemcitabine and Cisplatin are currently the first line-treatment for patients diagnosed with NSCLC, and the addition of Necitumumab looks to be a promising happening on the horizon. Not only was the addition of Necitumumab to the Gemcitabine and Cisplatin pair tolerable in studies, overall survival rates significantly improved with the new trio of treatments.

Results from the successful phase III clinical trial which combined Gemcitabine, Cisplatin and Necitumumab have been encouraging. Approximately 1,093 patients were enrolled in this landmark study, which demonstrated a median overall survival time of 11.5 months for patients treated with all three drugs. Compared to patients who were dosed with Gemcitabine and Cisplatin only, there was a definite improvement in overall survival rates- 11.5 months versus 9.9 months, respectively. The aforementioned study, coined SQUIRE, included 184 investigative sites in 26 countries. All of the patients in the study had stage IV squamous NSCLC and were admitted to the study, regardless of their EGFR mutation status. A 3-week schedule is most often administered when dosing both Gemcitabine and Cisplatin, and this was the case in the SQUIRE study. Of the 1,093 patients, 545 patients were randomized to receive Gemcitabine and Cisplatin plus Necitumumab and 548 patients were dosed Gemcitabine and Cisplatin only. Exactly 800 milligrams of Necitumumab was administered to patients on day 1 and 8 every 3 weeks. In both groups Gemcitabine was dosed at 1250 mg/m2 on days 1 and 8 and 75 mg/m2 of Cisplatin was given on day 1 only. Patients were balanced in both of the study arms, with statistical data revealing an average participant age of 62, with 84 percent of patients being of the Caucasian ethnicity and 91 percent of people being smokers. More information will be presented in September 2015 at the 16th World Conference on Lung Cancer.

As the most commonly diagnosed form of lung cancer NSCLC accounts for roughly 85 percent of all lung cancer patients. The squamous form of NSCLC is less common, and effects less patients, but is much more difficult to treat effectively. Unfortunately the majority of patients are diagnosed with squamous NSCLC when the disease has progressed extensively, leaving an average five year survival rate of less than five percent. Further R&D is needed using the effectual Gemcitabine and Cisplatin products.

LGM Pharma can assist clients as a supplier/distributor of the APIs Gemcitabine, CAS # 95058-81-4 and Cisplatin CAS #15663-27-1 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.

 

Sonidegib FDA Approved as Once Daily Treatment for Locally Advanced Basal Cell Carcinoma

Wednesday, August 5th, 2015

Sonidegib FDA Approved for Locally Advanced Basal Cell CarcinomaOn July 24, 2015 the FDA approved Sonidegib, marketed by Novartis AG as the once daily pill Odomzoa for the treatment of locally advanced basal cell carcinoma. Specifically for patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.

Sonidegib, also known as the compound LDE225, had recently captured the attention of the pharmaceutical and medical industry worldwide, due to extremely successful study data. Conducted by Novartis, the reports from a Phase 2 study have shown Sonidegib to be a top-notch drug, eradicating basal cell carcinoma in a number of patients. Dispensed as an oral treatment for patients suffering from advanced basal cell carcinoma, the study results easily met the primary endpoint, garnishing an objective response rate within six months’ time. The objective response was based on the criteria of the complete absence of advanced basal cell carcinoma, and clinically sizable tumor shrinkage. The pharmaceutical industry was poised for an earlier than planned FDA application from Novartis, based on these incredible Phase 2 results.

smoothendAs an effectual drug that inhibits a receptor coined smoothened, that regulates the hedgehog signaling pathway, Sonidegib efficiently and safely blocks tumor growth. With basal cell carcinoma accounting for over 80 percent of non-melanoma cancers, treatments for advanced stages of this form of skin cancer are urgently needed. The advent of an easy to dispense oral treatment to fight this now common cancer worldwide offers hope for a greater number of patients. Around the world there is a 10 percent incident increase of basal cell carcinoma every year, which is likely due to an aging population and greater exposure to dangerous ultraviolet rays. Basal Cell Carcinoma does not often metastasize, but more advanced cases of this regularly seen disease are manifesting. The exciting data gleaned from Novartis’s study of Sonidegib showcasing patients who achieved complete remission is nothing short of miraculous.

LGM Pharma provides Sonidegib CAS# 956697-53-3, 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.

Can Brivaracetam Reverse Memory Impairment in Alzheimer’s Patients?

Thursday, July 30th, 2015

While Brivaracetam is being evaluated as an adjunctive therapy in patients diagnosed with Epilepsy and partial onset seizures, animal models have piqued the curiosity of R&D experts as to Brivaracetam being a potential treatment for Alzheimer’s patients. As a unique product with a high-affinity synaptic vesicle protein 2A ligand, Brivaracetam is currently marketed by UCB, which announced both US and EU regulatory filings in January 2015. Ongoing study remains a standard for this investigational antiepileptic drug, with new information being shared regarding this novel and effectual product in a timely fashion.

Brivaracetam

 

Mouse-mazeRecent studies emerged on mice who possessed various strains of transgenic Alzheimer’s disease and who were given the antiepileptic drugs Ethosuximide and Brivaracetam. The idea was that these drug therapies would suppress epileptiform activity and reverse memory impairments and synapse loss in the mice. Results were intriguing, with two transgenic mouse models of Alzheimer’s disease showed a presence of spike-wave discharges which correlated with impairments in their spatial memory. While both Ethosuximide and Brivaracetam were shown to reduce spike-wave discharges, only Brivaracetam reversed the memory impairments in the mice. Further study is in order to determine if Brivaracetam can treat humans with Alzheimer’s disease.

The importance of Brivaracetam to treat epilepsy is paramount, and study investigators are anxiously awaiting FDA and EU approval. As one of the most common neurological issues epilepsy is believed to affect roughly 1% of the population worldwide. Only one-third of patients achieve seizure control from current drug therapies approved today, leaving a great need for new and efficacious treatments. As a Levetiracetam derivative Brivaracetam is a second generation therapy which has proven successfully in studies to target the synaptic vesicle protein 2A. Brivaracetam has also shown in trials to have efficacy for the treatment of progressive myoclonus epilepsy, and it is also in development to become a potential add-on treatment for focal epilepsy. Brivaracetam has demonstrated tolerability in many studies of patients with epilepsy. Three phase 3 studies, which involved more than 3,000 adults and children have been conducted, with one specific phase 3 study being deemed extremely successful. This study included 398 adult patients with epilepsy in a placebo controlled and double blind trial. The adults who were administered 100 milligrams daily of Brivaracetam experienced a reduced rate of baseline-adjusted focal seizures by 11.7% over the patients who were dosed with the placebo. Additionally, 36% of the patients who received Brivaracetam had a seizure reduction of 50% or greater as compared to the placebo patient population. The future looks bright for Brivaracetam.

LGM Pharma can assist clients as a supplier/distributor of the API Brivaracetam CAS# 357336-20-0 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.