25 February 2005

Durogesic(R) - Jansen-Cilag

DTrans(R) fentanyl matrix delivery system, a patch that is applied to the skin and provides reliable pain relief for people with severe chronic pain. Durogesic(R) DTrans(R) provides 3 days continuous analgesia from each single patch application.

Durogesic(R) DTrans(R) contains the synthetic opioid fentanyl, which has a 30-year worldwide history of pain relief and an established safety profile. The treatment offers effective, round-the-clock relief from pain for three days, (1) avoiding the "peaks and troughs" seen with some oral medications thus improving patient compliance. (1) With previous transdermal therapies up to 80% larger in size compared to Durogesic(R) DTrans(R), (2) it is discreet and comfortable to wear and should improve the quality of life for people with chronic pain.

A recent survey of almost 300 GPs (analysed by Synergy Healthcare Research), found that 87% of GPs agreed that strong opioids offered people with severe chronic pain the best opportunity to achieve acceptable pain control, and would prescribe them for appropriate patients. (3)

Chronic pain affects over 8.5 million people in the UK (4) or approximately 10% of the population, yet 96% of General Practitioners (GPs) believe there is significant room for improvement in methods of treatment. (5) Durogesic(R) DTrans(R) is being launched alongside 'Translating Pain', an educational initiative supported by Pain Concern, a national organisation providing information and support for pain sufferers and their carers, and endorsed by actor and former chronic pain sufferer Nigel Planer, to encourage better communication between patients and their GP, ensuring effective treatment and pain relief.

- Durogesic(R) DTrans(R) is applied to the skin and provides reliable consistent pain relief for patients with lower back pain, osteoarthritis, rheumatoid arthritis, neuropathic pain, cancer- and non-cancer-associated pain.

- The new system currently is available in four dosage strengths: 25 micro g/hr, 50 micro g/hr, 75 micro g/hr and 100 micro g/hr. It has been specially designed to deliver between 25 micro g and 100 micro g of fentanyl per hour for up to 72 hours. If necessary, multiple systems can be worn to achieve higher doses.

- Previous transdermal therapies are up to 80% larger in size compared to Durogesic(R) DTrans(R) (1)

6 January 2005
Duloxetine HCl - for depression - Eli Lilly
Cymbalta(R)/Xeristar(R) Approved in European Union to Treat Major Depressive Episodes

Cymbalta/Xeristar, a balanced dual-reuptake inhibitor of serotonin and noradrenaline (norepinephrine), has been studied in more than 6,000 adults with major depression worldwide. Safety and efficacy have been demonstrated in four positive acute placebo-controlled clinical trials and a relapse prevention study.

"This is a significant breakthrough as clinical trials show Cymbalta to be a very effective antidepressant," said Robert Peveler, MA, DPhil, FRCPsych, Professor of Psychiatry at the University of Southampton , United Kingdom. "And, unfortunately, there are still a significant number of people suffering from depression in Europe despite the advances in modern medicine."

Researchers believe Cymbalta/Xeristar is effective in treating the emotional and somatic symptoms of depression due to its dual action on two key neurotransmitters, serotonin and noradrenaline. These neurotransmitters are believed to help regulate emotions and sensitivity to pain. Scientists believe that if these neurotransmitters are out of balance, a person may become depressed and be more likely to feel emotional and somatic symptoms. The combination of emotional and somatic symptoms of depression can have a tremendous negative impact on a person's quality of life.

Emotional symptoms include sadness, anxiety, low mood and hopelessness. Somatic symptoms can include fatigue, vague aches and pains, and shoulder, neck and back pain.

Note

Duloxetine for major depressive episodes will be marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta(R), except for Greece , Italy and Spain . In Greece , Italy and Spain Lilly will market the product as Cymbalta and Boehringer Ingelheim will market the product as Xeristar(R). In the USA the collaboration does not include Cymbalta.

Duloxetine for stress urinary incontinence will be marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Yentreve, except for Greece , Italy and Spain . In Greece , Italy and Spain Lilly will market the product as Yentreve and Boehringer Ingelheim will market the product as AriClaim(R).

References

(1) Ayuso-Mateos JL, et al. Brit J Psychiatry. 2001; 179:308-316.

(2) Wittchen HU, et al. J Clin Psych. 2001; 62 (suppl. 26).

(3) Tran PV, Bymaster FP, McNamara RK, et al. Dual Monoamine Modulation for Improved Treatment of Major Depressive Disorder, J Clin Psychopharmacology, 2003; 23: 78-86.

4) Thase ME. J Clin Psychiatry. 1999; 60 (suppl 22):35-36.

5) Hirschfeld RM, et al. JAMA. 1997; 277: 333-340.

 (6/1/05)