The 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.
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