Potentially life-changing new treatments to manage Parkinson's disease are emerging from research related to this progressive neurological condition. Nearly 1 million individuals in the US have the disease, and it is estimated that there are 50,000 new diagnoses each year. Parkinson's disease results in motor symptoms (eg, resting tremor, postural instability, rigidity) and nonmotor symptoms (eg, mood disorders, loss of sense of smell, sleep disturbances, sexual problems). While there is not yet a cure, the treatment options to manage the disease's symptoms are continually advancing.
Earlier this year, Nuplazid (pimavanserin), the first drug approved by the FDA to treat hallucinations and delusions associated with Parkinson's disease, became available. It was granted breakthrough therapy designation and a priority review. Nearly 50% of patients with Parkinson's disease have the potential to experience hallucinations or delusions. In a clinical trial, Nuplazid demonstrated superior effectiveness compared to placebo in decreasing the frequency and/or severity of hallucinations without worsening primary motor symptoms of Parkinson's disease.
Levodopa is still the mainstay for treatment of Parkinson's disease, but among the emerging drug therapies is a possible new form: inhaled levodopa. The experimental form is intended to provide relief of motor symptoms during "off" periods (the times when symptoms return in between regular doses of oral levodopa). The phase II study has completed, which entailed testing the new inhaled formulation in 86 people (average age of 62) with Parkinson's disease who experienced at least 2 hours of "off" time per day despite taking 4 or more doses of oral levodopa. Compared to participants who took placebo, those who took the inhaled medication had significant improvement in their motor symptoms with about an hour less in "off" periods, and did not experience dyskinesias that often happen at the peak effect of oral levodopa. Further research with larger groups is underway.
Because people who take levodopa may experience "wearing-off" periods, entacapone is commonly prescribed to reduce these periods, but a possible new drug therapy may provide another option. Opicapone (a COMT inhibitor) has a completed phase III trial with 600 study participants that compared the effects of treating "wearing-off" with 3 different doses of opicapone, placebo, and entacapone. The results showed that a 50mg daily dose reduced "off" time as effectively as entacapone and that compared to placebo, opicapone 50mg/day reduced "off" time by about 60 minutes a day, while entacapone reduced "off" time by 40 minutes a day. Opicapone may offer an additional approach to coping with "wearing-off" effects associated with Parkinson's disease.
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Salvatore Volpe, MD, FAAP, FACP, CHCQM
Chief Medical Officer
PDR