Back in 2011, two British professors, Guy Goodwin (Oxford University) and David Nutt (Imperial College London), co-authored a report entitled “Funding crisis threatens development of new treatments for mental illness – urgent action needed”. Their report, published by the European College of Neuropsychopharmacology, raised serious concerns that the withdrawal by major pharmaceutical companies from research into mental disorders such as depression and schizophrenia signaled "a withdrawal of hope for patients and their families”. This concern was not unfounded. Companies like GSK,
My guess is that this was a hard decision for each company. Neuropsychopharmacology is an important area of research. However, in the face of dwindling resources to commit to R&D, even the biggest companies are making difficult decisions as to what areas of research to fund. Given that there are drugs to treat depression and schizophrenia, many of which are generic, companies that have stayed in CNS research have focused on other medical needs such as Alzheimer’s Disease, Parkinson’s Disease and stroke.
Yet, the medical need in a disease like depression remains high. Existing drugs are effective in only half of patients with depression. Furthermore, these drugs can take 3 – 4 weeks before their beneficial effects are manifest. Finally, as with all drugs, these too have side effect issues. Thus, the need for safe and effective new antidepressants remains. Goodwin and Nutt recognize this in their report and fear that as the major pharmas have deemphasized this area of research there will be created “a dead space of 20 – 30 years before we can begin to do it again.”
Despite these worries, it appears that this situation may not be as dire as portrayed two years ago. While major companies may have moved on to other areas of research, small companies have stepped up to fill the void. Recently, Lundbeck reported promising data on Brintellix, a novel antidepressant that is effective in depression patients for whom current therapy is ineffective. For those who suffer from depression and for whom traditional SSRIs are ineffective, Brintellix could offer a degree of hope.
Shortly after Lundbeck reported its results, another small company, Alkermes, also made a splash with a novel approach to treat depression. This new experimental drug, known as ALKS- 5461, acts by modulation of opioid receptors – a totally new approach to treating depression. In a Phase 2 study of this non-addictive, oral, once-daily medicine, ALKS-5461 showed clinically meaningful efficacy that was, according to Dr. Maurizo Fava, a leading researcher at Massachusetts General Hospital, “among the most robust I have seen in a phase 2 study for depression in the past two decades”.
Clearly, Professors Goodwin and Nutt would like to see all of the major pharmaceutical companies intimately involved in neuropsychopharmacology research. But despite the fact that many have abandoned this field, the biopharmaceutical ecosystem is such that an important research area like this never really gets ignored. My sense is that the same thing is happening in other areas such as antibiotics for resistant infections. Perhaps the smaller companies will have success and lead the way for the big companies to recommit to diseases in these important areas where patients still need better drugs.
