Thursday 13 August 2015

Topical Clonidine (Neuropathic Pain) - Regulatory Environment,Key Challenges,Share and Size,Forecast and Market Analysis to 2022

Summary

Neuropathic pain (NP) is defined as a disorder of the sensorimotor system and is distinctly different from nociceptive pain, which is a consequence of trauma, injury, or inflammation. The main difference between neuropathic and nociceptive pain is the absence of a continuous nociceptive input in neuropathic pain. Although the term neuropathic pain is used to describe a wide range of pain syndromes with varying etiologies, this report focuses on 3 distinct forms of NP: Painful diabetic neuropathy, Postherpetic neuralgia and trigeminal neuralgia. The main classes of drugs used to treat these three neuropathic pain indications include anticonvulsants, antidepressants, opioids and topical treatments. However, despite the availability of multiple pain medications only 50% of patients respond to any given drug and there are numerous the side effects associated particularly with systemically administered drugs, that reduce their tolerability. New treatments will target some key unmet needs in terms of efficacy and tolerability, but opportunities will remain for drugs that can more reliably eradicated NP in targeted patient populations, as well as offering an improved safety profile.
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BioDelivery Sciences International (BDSI) is currently planning Phase III clinical trials of a Topical Clonidine gel (0.1% clonidine hydrochloride) for the treatment of PDN, after the company entered into a worldwide licensing agreement with Arcion Therapeutics for clonidine in March 2013. Arcion had previously completed Phase II trials of the drug in PDN in December 2009, the results of which showed that it was effective in reducing pain associated with PDN, particularly in subjects with evidence of preserved nociceptors. In September 2010, Arcion Therapeutics received a Fast-Track designation from the FDA for the topical clonidine gel for the treatment of pain associated with PDN.

Scope

  • Overview of Neuropathic pain, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Topical Clonidine including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Topical Clonidine for the top six countries from 2012 to 2022.
  • Sales information covered for the US, France, Germany, Italy, Spain and the UK.


Reasons to buy

  1. Understand and capitalize by identifying products that are most likely to ensure a robust return
  2. Stay ahead of the competition by understanding the changing competitive landscape for Neuropathic pain
  3. Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  4. Make more informed business decisions from insightful and in-depth analysis of Topical Clonidine performance
  5. Obtain sales forecast for Topical Clonidine from 2012-2022 in the top six countries (the US, France, Germany, Italy, Spain and the UK).

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Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
3 Disease Overview
3.1 Clinical Manifestations of Neuropathic Pain Signs and Symptoms
3.1.1 Painful Diabetic Neuropathy
3.1.2 Postherpetic Neuralgia
3.1.3 Trigeminal Neuralgia
3.2 Etiology and Pathophysiology
3.2.1 Etiology
3.2.2 Pathophysiology
4 Disease Management
4.1 Diagnosis and Treatment Overview
4.1.1 Diagnosis
4.1.2 Treatment Overview and Guidelines
5 Competitive Assessment
5.1 Overview
6 Unmet Need and Opportunity
6.1 Overview
6.2 Physician Knowledge or Awareness
6.2.1 Unmet Need
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 Diagnostic Challenges
6.3.1 Unmet Need
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 Low Treatment Rate and Underdosing of Medications
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