Allergan Plc. Is The Global Pharmaceutical Company Essay
Allergan Plc. Is The Global Pharmaceutical Company, 484 words essay example
Essay Topic: global
Allergan plc. (NYSE AGN) has announced that rapastinel (GLYX-13), once-weekly intravenous Phase 3-ready molecule, has achieved the Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) to be used as a secondary treatment for Major Depressive Disorder (MDD).
The drug has been given green signal for the Phase III trials. Rapastinel was given Fast Track Designation by the FDA in 2014.
The results of the STAR*D trial showed that only 33% of patients complained of remission of their MDD symptoms after using only SSRI (selective serotonin reuptake inhibitor). The patients took two to six weeks for the improvement of their depressive symptoms after being on SSRIs.
The patients on monoamine-based therapy for the same duration showed significant depressive symptoms including suicidal ideation in patients with severe, recurrent, or chronic depression.
The registration Phase 3 trials are expected to begin in 2016. Rapastinel was granted Fast Track designation by the FDA in 2014.
The preclinical and preliminary clinical data of the drug is the main source for the Breakthrough Therapy designation. The clinical data proved that rapastinel provides a very quick antidepressant effect in the Phase II studies. The tolerability of the drug is proved to meet the primary endpoint along with no complaints of psychotomimetic or hallucinogenic side effects.
Allergan plans to initiate phase 3 studies of rapastinel in 2016.
Rapastinel (GLYX-13) belongs to an investigational intravenous formulation of a novel NMDA receptor partial agonist, which is being evaluated for adjunctive treatment of MDD.
Major Depressive Disorder (MDD) affects approximately 16 million people in US. Majority of the patients suffering from MDD do not respond to the first-line treatment therapy including the SSRIs and SNRIs.
The therapeutic market of MDD is divided into many segments, which include Tricyclic antidepressants (TCAs), Serotonin norepinephrine reuptake inhibitors (SNRIs), Selective serotonin reuptake inhibitors (SSRIs), Monoamine oxidase inhibitors (MAOIs), and atypical antidepressants.
Noteworthy drugs in treating MMD includes Cymbalta by Eli Lilly with a market share of $1,615 million, Pristiq by Pfizer and Zoloft with a sale of $423 million and $737 million, Paxil marketed by GSK clinched a share of $319 million in 2014.
The companies working in the MDD market incudes H. Lundbeck A/S, Otsuka Pharmaceutical Co., Ltd., AstraZeneca Plc, Alkermes, Takeda Pharmaceutical Company Limited, Eli Lilly and Company, and Pfizer Inc.
Allergan is working very hard in the psychiatry and neurology segments. In August of 2015, the drug maker has acquired Naurex Inc., a biopharmaceutical company developing drugs for the central nervous system.
This acquisition helps the Allergan's pipeline to be stronger in mental health. By virtue of this acquisition, the drug maker gets the rights of Rapastinel and NRX-1074. Both therapies proved their efficacy and safety profile in patients suffering from MDD.
At present the company is marketing Viibryd with a sale of $140 million in 2014, Namenda for the treatment of schizophrenia with a sale of $899 million in 2014 along with the drug maker's strong late-stage mental health related drug profile covering the central nervous system.