This year’s Mental Health Awareness Week: 14th – 20th May, hosted by the Mental Health Foundation will focus on stress, one of a large spectrum of mental health disorders, with some of the most well-known being depression, schizophrenia, and bipolar disorder.
Maura Musciacco, MSc, Director of Neurology & Ophthalmology at GlobalData, a leading data and analytics company, commented, ‘‘Mental health issues can be severely debilitating, and can impact all aspects of a patient’s life, including health, education, employment, and social interactions. GlobalData’s primary research, shows that the unmet needs for these indications are often over-lapping and a common denominator here is the need to find medications with improved efficacy and safety profiles.’’
The markets for mental health treatments are competitive and crowded with a multitude of approved therapies, many of which are available as inexpensive generics. Despite a large number of drugs on the market, key opinion leaders interviewed by GlobalData explained that they do not significantly differ from each other in terms of efficacy, but have a slightly different safety profile.
Musciacco, continued, ‘‘Due to the high number of side effects seen with all treatments, there is a large unmet need for efficacious drugs with an improved safety profile. This, in turn, would improve compliance and improve treatment rates. Furthermore, none of the marketed products for depression can demonstrate rapid antidepressant effects, and most of the products take weeks to show effectiveness. The need for fast-acting therapies is more pressing in patients with the severe form of the disease, who, in many cases, have to be hospitalized.’’
The development of drugs with enhanced safety profiles has been highlighted consistently as an unmet need for these mental health disorders.
In the case of schizophrenia, the most notable side effect caused by current treatments are metabolic effects, such as weight gain and extrapyramidal symptoms (EPS), especially for typical (or first-generation) antipsychotics. Key opinion leaders (KOLs) in the industry explained that metabolic syndrome is the most challenging aspect when treating their schizophrenic patients. Other side effects of concern include drowsiness/sedation and decreased cognitive function, which can have major impacts on the patient’s quality of life.
Similarly for depression, the available pharmacotherapies are associated with significant and often serious side effects and associated risks. Different antidepressants and adjunctive therapies have different safety profiles, and in general, the side-effect burden is high, with weight gain and sexual dysfunction being identified through GlobalData’s primary research as the most undesirable of these.
The bipolar disorder treatment algorithm typically involves treating patients long-term with one of the mood stabilizers, such as lithium. Safety concerns associated with these products vary; however, each product carries a risk of serious side effects. Lithium is considered to be the gold-standard maintenance treatment for bipolar disorder; however, it is associated with a plethora of safety concerns, including thyroid and parathyroid abnormalities, weight gain, and an increased risk for reduced urinary concentrating ability. In order to manage these concerns, a patient’s plasma concentration must be closely monitored; the development of side effects necessitates a reduction in dosage, which can significantly affect efficacy.
Musciacco added, ‘‘Opportunities exist for products that will meet the significant unmet needs in these markets. Products that have improved efficacy and safety profiles, will be viewed favorably and will have significant competitive advantages, which would enable them to potentially move to the forefront of the treatment line and gain significant market share in these increasingly crowded markets.’’