Bipolar I Disorder affects ~0.6% of the general population, representing approximately 1.7 million people in the US


Bipolar disorder can be characterized by periods of severe mood episodes, oscillating between mania and depression. Manic episodes may include elevated mood or extreme irritability, and behavioural changes such as being unusually distracted, overly restless, having unrealistic belief in own abilities, or being impulsive and engaging in pleasurable, high risk behaviours. Depressive episodes may include overly long periods of being in a depressed mood as well as behavioural changes such as feeling overly tired, having problems concentrating, remembering and making decisions, loss of interest in activities once enjoyed and suicidal ideations. According to the criteria defined in DSM-IV-TR, patients with bipolar I disorder will have experienced at least one episode of mania; they may have experienced mixed, hypomanic and depressive episodes as well. Patients with bipolar II disorder have experienced hypomanic and depressive episodes. The suicide rate in the bipolar disorder population is 20x higher than the general population. 

Current Treatment

Treatment of bipolar disorder is focused on acute stabilization of mood and on prevention of relapse. First-line therapy for more severe manic or mixed episodes involves the initiation of either lithium plus an antipsychotic or valproate plus an antipsychotic. For mild to moderate episodes, monotherapy with lithium, valproate, or an antipsychotic may be sufficient. Atypical antipsychotics, such as aripiprazole, are preferred over typical antipsychotics due to their lower side effect profile. Depressive episodes are treated first-line with either lithium or lamotrigine. Antidepressant monotherapy is not recommended, but may be used as adjunctive therapy in more severe patients.

Following remission of an acute episode, patients remain at particularly high risk of relapse for a period of up to 6 months; this phase of treatment is referred to as either the continuation or maintenance phase. A medication that was used to achieve remission from the most recent episode, generally should be continued. During the maintenance phase, patients with bipolar disorder are likely to benefit from a psychosocial intervention concomitant to their prescribed pharmacotherapy, such as psychotherapy that addresses adherence, lifestyle changes, and early detection of symptoms. Patients who continue to experience breakthrough mood episodes may require the addition of another maintenance medication.


Unmet Medical Needs


Non-adherence to medication is a major problem in Bipolar I patients and is one of the highest contributing factors to relapse. Approximately 51.9% of Bipolar Disorder patients are adherent to their medications; non-adherence has substantial consequences in Bipolar Disorder as with each additional episode a patient suffers, the next is documented to be more frequent, more severe, and increasingly more difficult to treat.  A once-weekly transdermal alternative could address this challenge by improving ease of administration for patients.