10/11/2013

Florence, October 11th, 2013. – Worldwide millions of patients are tortured by a pain that is unexplainable for them. They often describe it as burning, stabbing, shooting, hot pins and needles or electric shocks. Even if patients and their general practitioners (GPs) recognize this pain as neuropathic pain or nerve pain, that is defined as ‘a direct consequence of a lesion or disease affecting the somatosensory system¹, they often undergo stepwise treatment approaches or trial and error medication strategies. Only 40-60% of patients achieve adequate pain relief.^[2] In a series of Meet-the-expert sessions hosted by Grünenthal at the 8th EFIC Pain in Europe congress in Florence, Italy, experts explained that in approximately 60% of cases, neuropathic pain is localized affecting a specific circumscribed area of the body³. LNP is often seen in patients with chronic pain after shingles (post-herpetic neuralgia).³ As an easy, reliable tool for screening localized neuropathic pain (LNP) patients is missing, the international pain experts Prof Ralf Baron, Germany, Dr. Gérard Mick, France, Dr Gerardo Correa-Illanes, Chile, Dr Victor Mayoral, Spain and Prof Guy Hans, Belgium developed a screening tool for GPs to identify LNP as a type of neuropathic pain.

A new diagnostic tool to improve the diagnosis of LNP

The LNP screening tool presents itself as a DIN A 6 pocket card with four decision making questions about patient’s history, testing of signs and symptoms, and the location and size of the painful area. A pictorial guidance shows GPs how to conduct a neurological sensory examination with objects and devices of their daily routine for example pencils or Q-tips. “The LNP Screening Tool was evaluated by 31 general practitioners (GPs), who screened 2079 patients in the Badalona Municipal Hospital, Spain and considered as very helpful”, explained Dr Mayoral, Spain, “and we are convinced that this tool will improve early diagnosis of LNP and thus facilitate targeted treatments.” A typical localized neuropathic pain condition is post-herpetic neuralgia (PHN), often referred to as post-shingles pain or after-shingles pain. This pain persists three months or more after the healing of herpes zoster lesions or rash. PHN may develop after a pain-free interval⁴. The incidence of PHN increases with age and has been reported to be 11 per 100,000 persons.⁵

Think outside the pill box to overcome treatment challenges in PHN

“One of the great challenges when treating PHN patients is that they intend to be elderly with a lot of other medical comorbidities and a lot of medication”, explains Dr Mick Serpell, UK. “So you want something which is simple, well tolerated and effective.” Many of the treatment options for post-herpetic neuralgia are associated with serious side effects leading to high level of dissatisfaction with therapy and influencing pa-tients’ quality of life⁶. With its proven efficacy of 62% responder rate, which is comparable to systemic treatment⁷ the 5% lidocaine medicated plaster (Versatis®) shows an excellent tolerability profile with a low risk of side effects and drug-drug interactions⁸ and less than 5% treatment discontinuations due to adverse drug reactions⁸. For many PHN patients, pain is a constant companion in life. Their chronic pain lasts for a long time and causes serious physical and social disability⁹.

PHN patients benefit from the long-term efficacy of the 5% lidocaine medicated plaster and a reduction of concomitant medication during treatment^10,11

Assessing efficacy for up to four years, and collecting tolerability data as well as physicians’ assessment of the medication, researchers confirmed the sustained longterm efficacy of 5% lidocaine medicated plaster.¹⁰ With the focus on the specific needs of the elderly and polymedicated target group of PHN patients, Dr Rodrigue Deleens, France, presented the outcome of a compassionate use programme (CUP) amongst 273 French patients whose previous PHN treatment with antidepressant and/or antiepileptic agents was inadequate or was not tolerated. The results of the CUP showed that PHN treatment with the 5% lidocaine medicated plaster leads to a significant quantitative reduction in concomitant treatments.¹¹

A natural way of application – it works where it hurts

“One of the many benefits of 5% lidocaine medicated plasters is its topical administration which is associated with low systemic side effects”, said Dr Massimo Allegri, Italy. “My patients like it. They feel pain relief and appreciate the way of application. It is easy to use for them – very natural – because the plaster is placed on the painful area.” Titration is not necessary and patients can use up to three plasters to cover the most painful parts⁸. “It's important to think outside the pill box when treating PHN patients. By using a targeted topical treatment instead of a systemic therapy you can minimize the risk of systemic side effects and you can also reduce the incidence of drug-drug interactions and frankly patients prefer not to take another pill”, said Dr Mick Serpell.

About Grünenthal

The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-cent

Florence, October 11th, 2013. – Worldwide millions of patients are tortured by a pain that is unexplainable for them. They often describe it as burning, stabbing, shooting, hot pins and needles or electric shocks. Even if patients and their general practitioners (GPs) recognize this pain as neuropathic pain or nerve pain, that is defined as ‘a direct consequence of a lesion or disease affecting the somatosensory system¹, they often undergo stepwise treatment approaches or trial and error medication strategies. Only 40-60% of patients achieve adequate pain relief.^[2] In a series of Meet-the-expert sessions hosted by Grünenthal at the 8th EFIC Pain in Europe congress in Florence, Italy, experts explained that in approximately 60% of cases, neuropathic pain is localized affecting a specific circumscribed area of the body³. LNP is often seen in patients with chronic pain after shingles (post-herpetic neuralgia).³ As an easy, reliable tool for screening localized neuropathic pain (LNP) patients is missing, the international pain experts Prof Ralf Baron, Germany, Dr. Gérard Mick, France, Dr Gerardo Correa-Illanes, Chile, Dr Victor Mayoral, Spain and Prof Guy Hans, Belgium developed a screening tool for GPs to identify LNP as a type of neuropathic pain.

A new diagnostic tool to improve the diagnosis of LNP

The LNP screening tool presents itself as a DIN A 6 pocket card with four decision making questions about patient’s history, testing of signs and symptoms, and the location and size of the painful area. A pictorial guidance shows GPs how to conduct a neurological sensory examination with objects and devices of their daily routine for example pencils or Q-tips. “The LNP Screening Tool was evaluated by 31 general practitioners (GPs), who screened 2079 patients in the Badalona Municipal Hospital, Spain and considered as very helpful”, explained Dr Mayoral, Spain, “and we are convinced that this tool will improve early diagnosis of LNP and thus facilitate targeted treatments.” A typical localized neuropathic pain condition is post-herpetic neuralgia (PHN), often referred to as post-shingles pain or after-shingles pain. This pain persists three months or more after the healing of herpes zoster lesions or rash. PHN may develop after a pain-free interval⁴. The incidence of PHN increases with age and has been reported to be 11 per 100,000 persons.⁵

Think outside the pill box to overcome treatment challenges in PHN

“One of the great challenges when treating PHN patients is that they intend to be elderly with a lot of other medical comorbidities and a lot of medication”, explains Dr Mick Serpell, UK. “So you want something which is simple, well tolerated and effective.” Many of the treatment options for post-herpetic neuralgia are associated with serious side effects leading to high level of dissatisfaction with therapy and influencing pa-tients’ quality of life⁶. With its proven efficacy of 62% responder rate, which is comparable to systemic treatment⁷ the 5% lidocaine medicated plaster (Versatis®) shows an excellent tolerability profile with a low risk of side effects and drug-drug interactions⁸ and less than 5% treatment discontinuations due to adverse drug reactions⁸. For many PHN patients, pain is a constant companion in life. Their chronic pain lasts for a long time and causes serious physical and social disability⁹.

PHN patients benefit from the long-term efficacy of the 5% lidocaine medicated plaster and a reduction of concomitant medication during treatment^10,11

Assessing efficacy for up to four years, and collecting tolerability data as well as physicians’ assessment of the medication, researchers confirmed the sustained longterm efficacy of 5% lidocaine medicated plaster.¹⁰ With the focus on the specific needs of the elderly and polymedicated target group of PHN patients, Dr Rodrigue Deleens, France, presented the outcome of a compassionate use programme (CUP) amongst 273 French patients whose previous PHN treatment with antidepressant and/or antiepileptic agents was inadequate or was not tolerated. The results of the CUP showed that PHN treatment with the 5% lidocaine medicated plaster leads to a significant quantitative reduction in concomitant treatments.¹¹

A natural way of application – it works where it hurts

“One of the many benefits of 5% lidocaine medicated plasters is its topical administration which is associated with low systemic side effects”, said Dr Massimo Allegri, Italy. “My patients like it. They feel pain relief and appreciate the way of application. It is easy to use for them – very natural – because the plaster is placed on the painful area.” Titration is not necessary and patients can use up to three plasters to cover the most painful parts⁸. “It's important to think outside the pill box when treating PHN patients. By using a targeted topical treatment instead of a systemic therapy you can minimize the risk of systemic side effects and you can also reduce the incidence of drug-drug interactions and frankly patients prefer not to take another pill”, said Dr Mick Serpell.

About Grünenthal

The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company and thus to be a leader in therapy innovation. Grünenthal is one of the last five remaining research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. Research and development costs amounted to about 26 percent of revenues in 2012. Grünenthal’s research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies. Altogether, the Grünenthal Group has affiliates in 26 countries worldwide. Grünenthal products are sold in more than 155 countries. Today, approx. 4,400 employees are working for the Grünenthal Group worldwide. In 2012, Grünenthal achieved revenues of €973 mn.

More information: www.grunenthal.com.

Contact

Jeanette Hübsch
Senior Manager Versatis,
Grünenthal Europe & Australia
Phone: +49 241-569-1487
Email: jeanette.huebsch@grunenthal.com

Frank Schönrock,
Vice President Public Engagement
Tel.: +49 241 569-1568,
Fax: +49 241 569-3539,
frank.schoenrock@grunenthal.com

References:

¹ Treede RD et al. (2007). Neuropathic pain: Redefinition and a grading system for clinical and research purposes. Neurology; 70:1630-1635.

 ² Dworkin RH, O'Connor AB, Backonja M, et al (2007). Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain;132:237–51.

³ Mick G et al (2012). What is localised neuropathic pain? A first proposal to characterise and define a widely used term. Pain manage 2(1), 71-77.

 ⁴ Kost RG, Straus SK (1996). Postherpetic neuralgia-pathogenesis, treatment, ad prevention: N Engl J Med; 335 (1): 32-42

⁵ Sadosky A. et al.(2008). A review of the epidemiology of painful diabetic peripheral neuropathy, postherpetic neuralgia, and less commonly studied neuropathic pain conditions. Pain Pract; 8:45–56.

 ⁶ Oster G. et al. (2005). Pain, Medication use, and Health-Related Quality of Life in Older Persons With Postherpetic Neuralgia: Results from a Population-Basd Survey. Journ. of Pain; 6 (6): 356-63

 ⁷ Baron R. et al. (2009). 5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy: an open-label, non-inferiority two-stage RCT study. Curr Med Res Opin;25:1663 -76.

⁸ Grünenthal. Versatis® (lidocaine plaster 5%) Summary of Product Characteristics June 2012.

⁹ Dworkin RH et al. (2010). Recommendations for the Pharmacological Management of Neuropathic Pain : An Overview and Literature Update. Mayo Clin Proc ; 85(3)(suppl): S3-S14

¹⁰ Sabatowski R et al. (2012). Safety and efficacy outcomes of long-term treatment up to 4 years with 5% lidocaine medicated plaster in patients with post-herpetic neuralgia.Curr Med Res Opin; 28:1-10.

¹¹ Clère F et al (2011). 5% Lidocaine Medicated Plaster in Elderly Patients with Postherpetic Neuralgia Results ofaCompassionate Use Programme in France. Drugs Aging; 28 (9): 693-702

More information: www.grunenthal.com.

Contact

Jeanette Hübsch
Senior Manager Versatis,
Grünenthal Europe & Australia
Phone: +49 241-569-1487
Email: jeanette.huebsch@grunenthal.com

Frank Schönrock,
Vice President Public Engagement
Tel.: +49 241 569-1568,
Fax: +49 241 569-3539,
frank.schoenrock@grunenthal.com

References:

¹ Treede RD et al. (2007). Neuropathic pain: Redefinition and a grading system for clinical and research purposes. Neurology; 70:1630-1635.

 ² Dworkin RH, O'Connor AB, Backonja M, et al (2007). Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain;132:237–51.

³ Mick G et al (2012). What is localised neuropathic pain? A first proposal to characterise and define a widely used term. Pain manage 2(1), 71-77.

 ⁴ Kost RG, Straus SK (1996). Postherpetic neuralgia-pathogenesis, treatment, ad prevention: N Engl J Med; 335 (1): 32-42

⁵ Sadosky A. et al.(2008). A review of the epidemiology of painful diabetic peripheral neuropathy, postherpetic neuralgia, and less commonly studied neuropathic pain conditions. Pain Pract; 8:45–56.

 ⁶ Oster G. et al. (2005). Pain, Medication use, and Health-Related Quality of Life in Older Persons With Postherpetic Neuralgia: Results from a Population-Basd Survey. Journ. of Pain; 6 (6): 356-63

 ⁷ Baron R. et al. (2009). 5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy: an open-label, non-inferiority two-stage RCT study. Curr Med Res Opin;25:1663 -76.

⁸ Grünenthal. Versatis® (lidocaine plaster 5%) Summary of Product Characteristics June 2012.

⁹ Dworkin RH et al. (2010). Recommendations for the Pharmacological Management of Neuropathic Pain : An Overview and Literature Update. Mayo Clin Proc ; 85(3)(suppl): S3-S14

¹⁰ Sabatowski R et al. (2012). Safety and efficacy outcomes of long-term treatment up to 4 years with 5% lidocaine medicated plaster in patients with post-herpetic neuralgia.Curr Med Res Opin; 28:1-10.

¹¹ Clère F et al (2011). 5% Lidocaine Medicated Plaster in Elderly Patients with Postherpetic Neuralgia Results ofaCompassionate Use Programme in France. Drugs Aging; 28 (9): 693-702