Janssen’s Invega approved in Europe
pharmafile | July 12, 2007 | News story | Sales and Marketing |
Janssen-Cilag's once-daily schizophrenia treatment, Invega, has been granted European approval, making it the first oral, prolonged-release drug for the condition on the market.
Invega (paliperidone) is the company's follow-up to its highly successful atypical antipsychotic, Risperdal, which is due to lose patent protection in 2008.
Last year, in England and Wales, Risperdal (risperidone) accounted for £44 million of GP prescribing, compared to £108 million for Lilly's market leader Zyprexa (olanzapine).
In clinical trials, Janssen's Invega was found to reduce the positive and negative symptoms of the condition and improve day-to-day personal and social functioning.
Invega is the active metabolite of risperidone and works by fully blocking serotonin receptors, and partially blocks D2 dopamine receptors.
The drug uses the patented OROS technology, which releases the drug into the bloodstream steadily over a 24-hour period, and is intended to bypass some of the problems experienced with Risperdal.
Marjorie Wallace, chief executive at mental health charity Sane, said: "We are pleased that innovative delivery technologies are being applied to new treatments for schizophrenia. New treatment options such as Paliperidone are a significant opportunity for more people with schizophrenia to effectively manage their disease, working with their medical team to live more fulfilling and productive lives."
One in 100 people in the UK experience schizophrenia with the mental illness often appearing between the ages of 15-25 and 25-35, in men and women respectively.
The disease may affect individual patients throughout their lives, with relapses being marked by positive symptoms (hallucinations, delusions and disorganised thinking) and negative symptoms (depression, blunted emotions and social withdrawal).
"Paliperidone is a new, atypical antipsychotic with an innovative delivery system that can offer a more consistent release of medication," explained Dr. Helen Millar, Consultant Psychiatrist at the Carseview Centre, Dundee, Scotland.
"Clinical trials have shown that paliperidone is effective and generally well tolerated. Effective treatments for people with schizophrenia are important in helping to improve everyday functioning."
Invega's approval came on the back of a clinical trial programme involving more htan 1,200 patients across 23 countries.
Risperdal Oral was first launched in the early 1980s and more recently Jannsen-Cilag extended the franchise by launching Risperdal Quicklet and Risperdal Consta, a long-acting. injectable antipsychotic.
