Novel Shingles Pain Treatment Lauched In The UK

GrГјnenthal announced today that it has been granted a UK licence for its new product Versatis(R) (5% lidocaine medicated plaster). Versatis is licensed for the treatment of neuropathic pain associated with previous herpes zoster (shingles) infection, also known as post-herpetic neuralgia (PHN)1.

Versatis offers a topical and non-systemic approach for the treatment of localised neuropathic pain symptoms associated with PHN, often described as burning, shooting or stabbing. It is an innovative combination of the local anaesthetic lidocaine and a soft hydrogel plaster, combining efficacious treatment and simple handling with a proven tolerability and safety profile1.

The plaster offers rapid and continuous pain relief 30 minutes after application2. Following a once daily 12 hours-on/12 hours-off application schedule, up to three plasters can be used at one time. It can be used as monotherapy or in combination with patient's existing analgesia, and clinical trials have shown no clinically relevant drug interactions1.

The launch of Versatis coincides with the announcement of a new survey that shows the impact of PHN on quality of life. Conducted by the Barts Pain Research Group, the survey reveals that over 80% of respondents felt that PHN had negatively affected their ability to enjoy life, whilst almost 50% felt suicidal or depressed as a result of PHN3. Apart from the psychological impact of PHN, the condition has a significant impact on day-to-day activities, such as work, sleep and even getting dressed with one in three people not being able to participate in any day-to-day activities prior to treatment3. In addition, 92% of patients continued to suffer pain even whilst on treatment and over two thirds are dissatisfied with existing treatment options3.

"Versatis offers clinicians an effective and well-tolerated new treatment option for people suffering the debilitating shooting, stabbing and burning pain symptoms following shingles," said Professor Richard Langford, Professor of Anaesthesia & Pain Medicine at St Bartholomew's Hospital London. "It is generally older people who develop post-herpetic neuralgia after shingles and hence with their multiple morbidities and medications, the very low systemic level of lidocaine during Versatis use, minimises concerns about contraindications and drug interactions."

More than one million patients have been treated with the lidocaine plaster since 1999 in the US4. Marketed as Lidoderm(R) by Endo Pharmaceuticals its use demonstrates improved quality of life5 and better pain relief6 compared to their other treatments.В 

GrГјnenthal researches, develops and produces high therapeutic value medicines and markets them throughout the world. GrГјnenthal is an expert in drugs for pain therapy and gynaecology and a leader in the field of intelligent, user-friendly drug delivery technologies. GrГјnenthal is an independent, family-owned company with a long history of international co-operations. The company was founded in 1946 and has its headquarters in Germany. We supply our markets from seven production sites around the world and have affiliates in 27 countries. GrГјnenthal employs about 1,900 people in Germany and about 4,700 world-wide. Sales in 2005 amounted to approximately 777 million Euro.

-- Post-herpetic Neuralgia (PHN) is a prolonged neuropathic or nerve pain that follows an acute attack of shingles.

-- Shingles or herpes zoster is an acute infection caused by the reactivation of the latent varicella-zoster virus (chickenpox). After a childhood chicken pox infection the virus lies dormant in the dorsal root ganglia of the spinal cord. An acute shingles rash occurs when the virus is reactivated7.

-- PHN affects approximately 200,000 people in the UK8.

-- Older age is the risk factor most strongly associated with developing PHN and people aged 50 years or older are almost 15 times more likely to have pain 30 days after developing a shingles rash increasing to 27 times more likely after 60 days8.

References

1. Versatis Summary of Product Characteristics
2. Rowbotham MC et al. Pain 1996; 65: 39-44
3. The Barts Pain Research Group. Post-herpetic Neuralgia: The patient's voice.
4. GrГјnenthal data on file (Patient exposure)
5. Gammaitoni AR et al. Safety and Tolerability of the Lidocaine Patch 5%, a Targeted Peripheral Analgesic: A Review of the Literature. J Clin Pharmacol 2003;43: 111-117
6. Katz NP et al. Lidocaine Patch 5% Reduces Pain Intensity and Interference with Quality of Life in Patients With Postherpetic Neuralgia. Pain Med 2002; 3(4) 324-332
7. Prodigy Guidance: Shingles and post-herpetic neuralgia
8. Shingles Support Society. Bowsher D. Treatment of post-herpetic neuralgia in the elderlyl