|[May 06, 2014]
Research and Markets: Strategic Analysis of the Global Anti-Obesity Prescription Pharmaceuticals Market 2014
DUBLIN --(Business Wire)--
Research and Markets (http://www.researchandmarkets.com/research/qrrfhh/a_strategic)
has announced the addition of the "A
Strategic Analysis of the Global Anti-Obesity Prescription
Pharmaceuticals Market" report to their offering.
Prescription drug therapy for the treatment of obesity is experiencing a
revival of interest with new government incentives and the recent
approval of two new drugs, with two more pending imminent approval. This
research service focuses on the competitive landscape of prescription
drugs for the treatment of obesity. A global product and pipeline
assessment is provided for marketed and investigational products.
Segmentation by drug class is provided along with additional supporting
information, such as clinical-trial timelines and results, historical
and projected launch timelines, regulatory guidelines for clinical trial
design and approval, and global epidemiology by region.
The FDA recently approved 2 new prescription obesity treatments: Arena
Pharmaceuticals' Belviq (partnered with Eisai) launched in June 2013,
and Vivus' Qsymia, which became available September 2012. These FDA
approvals the first for obesity in more than a decade add new
therapeutic options to a market previously comprising a single
approved drug: Roche's Xenical.
A third new drug, Orexigen's Contrave, is pending FDA approval upon
successful demonstration of cardiac safety in an ongoing trial for
cardiovascular outcomes and resubmission of the new drug application
(NDA) in December 2013. A decision is expected from the FDA June 10,
2014, and in the second half of 2014 from the EMA (News - Alert). All three of these
new drugs were initially rejected by the FDA, which sought additional
confirmation of an acceptable safety prfile.
Approval of the obesity indication for Novo Nordisk's Victoza
(liraglutide) could come as soon as mid-2014, closely coinciding with
the potential approval of Contrave.
Market uptake of Qsymia and Belviq has been below expectations,
largely due to insurance reimbursement hurdles and possibly because of
physician and patient concerns about safety. Contrave, if approved,
may have better uptake in light of its designation as an uncontrolled
substance and stronger marketing capabilities of partner Takeda,
particularly to the primary care and diabetes communities.
Global medical and regulatory communities recognize the urgent need
for the pharmacotherapeutic treatment of obesity when lifestyle
interventions fail to adequately address excess body fat.
While numerous sympathomimetic amine anorectics such as phentermine,
benzphetamine, and diethylpropion are available by prescription,
association with serious side effects limits their use, and
prescribing is mainly limited to bariatric surgeons.
The global market potential for safe and effective obesity therapies
is significant; however, the discovery and development of efficacious
weight-loss drugs that are safe enough for chronic use has proven
challenging for even the most capable pharmaceutical and biotech
Ongoing research efforts are beginning to shed new light on the
pathology of obesity, as recent discoveries of differential gene
expression and genetic variants found in the different fat depots
advance our understanding of why abdominal fat is more strongly
associated with morbidity and mortality compared with subcutaneous
adipose tissue. Discoveries such as these could eventually lead to
targeted therapies aimed at reducing visceral adiposity.
Key Topics Covered:
1. Executive Summary
2. Methodology and Scope
3. Introduction to the Global Anti-obesity Prescription Drugs Market
Obesity Indication Background
Historical and Projected Timeline (News - Alert) for Anti-obesity Drugs
Potential Prescribing Behavior Scenario
Regulators' Recommendations for Designing Anti-obesity Drug Clinical
Regional Comparison of Drug Approval Requirements
Global Prevalence of Obesity by Region
Market Overview: Segmentation
4. Competitive Landscape
Anti-obesity Prescription Pharmaceuticals Market: Competitive Landscape
Ongoing Phase 3 Trials for Obesity Drugs
Ongoing Post-marketing Trials for Obesity Drugs
Comparative Efficacy of Obesity Drugs
Pivotal Trial Programs of Recently Approved Anti-obesity Drugs
Pivotal Trial Programs of Late-stage Anti-obesity Drugs
Marketed Products Synopsis (News - Alert)
Qsymia (phentermine/topiramat ER)
Belviq (lorcaserin HCl)
Contrave (bupropion SR/ naltrexone SR)
5. Conclusions and Recommendations
Alpex Pharma SA
For more information visit http://www.researchandmarkets.com/research/qrrfhh/a_strategic
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