Friday, April 03, 2009

Lower Back pain: New therapeutic opportunities open up for a “new” indication

An estimated 129 million adults suffer from back pain across the seven major markets.

Despite the size of this group of conditions, back pain remains an unmet clinical need characterized in equal measures by developmental challenges and market potential. No therapeutic agents have been specifically indicated for back pain and until recently the regulatory bodies have not even viewed the condition as a specific indication.

Our latest feature “Back Pain - Gain competitive edge by targeting subpopulations” sets out to examine key issues and unmet needs in the diagnosis and management of back pain. The report provides a thorough review of etiology, epidemiology, diagnosis and current treatment options. The report also explores potential commercial opportunities for companies intending to either penetrate, or increase, their share in this competitive market. Analysis is supported by interviews conducted with key opinion leaders in the US and Europe.

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The most important unmet need in the treatment of back pain to emerge from opinion leader interviews is for more targeted treatments. Therefore, the challenge to researchers is to provide evidence of which treatment, if any, is of most benefit for subgroups of patients with back pain. In order for this unmet need to be addressed, greater investment in basic science research is required to further our understanding of pain mechanisms.

Broadly speaking however back pain can be split into acute and chronic pain. Two areas of chronic pain under investigation are neuropathic back pain and breakthrough chronic back pain. Targeting back pain subpopulations represents a viable strategy and neuropathic back pain which affects an estimated 18 million adults across the seven major markets represents one such lucrative subpopulation.

Although targeting back pain subpopulations is viable, of the numerous companies are targeting neuropathic pain indications, to date no one product has a specific label for neuropathic back pain. Moreover, few pipeline drugs appear to be to be in development for this condition. This may in part be due to the regulatory bodies failing to recognize neuropathic back pain in its own right; it may also be due to the complexity of diagnosis.

Cephalon has tried and so far failed in breakthrough back pain with the FDA issuing a complete response letter relating to Fentora and its risk management program. Lilly has demonstrated that Duloxetine reduces back pain in individuals with depression. More directly, efficacy has also been reported in a Phase 3 chronic back pain trial with pain scores reduced by 2.4 points from baseline compared to 1.4 points on a standard 10-point rating scale. This effect was significant. Whether Lilly intends to file for a back pain label remains to be seen.

Most recently, Newron announced just this week that it has randomized the first patients to treatment in SERENA, its first phase IIb/III study of ralfinamide in patients with moderate neuropathic low back pain. Newron's ralfinamide now has the potential to become the first drug approved for the treatment of neuropathic low back pain. Ralfinamide is believed to mediate analgesic and anti-inflammatory effects through the modulation of ion channels implicated in pain and the inhibition of substance P.

A small Phase II study has previously shown that 33% of neuropathic low back pain patients demonstrated a 50% improvement following treatment with ralfinamide compared to 10% in a placebo group.

SERENA is one of potentially two large studies that will evaluate the safety and efficacy of ralfinamide compared to placebo. The study is a 12-week randomized trial being conducted in Europe and Asia that will randomize approximately 400 patients with chronic neuropathic low back pain. The primary efficacy measure of the trial will be based on the 11-point Likert Pain Scale. Secondary efficacy measures will include patients’ self ratings of the Visual Analogue Scale as well as responder rates. Patients who complete the 12 weeks of treatment will be eligible to enter a double-blind 40 week extension

Newron is anticipating SERENA data in H1 2010 and in the meantime is expecting to partner, presumably to conduct a similar study in the US and to passage through registration.

During the development of Ralfinamide various health authorities agreed that neuropathic low back pain would be treated as a specific indication. This and the headway being made by Newron suggest that other companies in the pain arena will also focus on back pain. This should hopefully result in new, and much needed treatments becoming available to patients by around 2011.

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