20 December 2024: AbbVie recently announced positive topline results from its pivotal Phase III TEMPO-2 trial evaluating investigational tavapadon as a flexible-dose monotherapy in early Parkinson’s disease (PD). Tavapadon, the first and only D1/D5 partial agonist in the dopamine agonist class, is under investigation as a once-daily treatment for PD. The trial met both its primary and secondary endpoints, suggesting that tavapadon has the potential to become a prominent treatment within the dopamine agonist market, says data and analytics company GlobalData.
Jos Opdenakker, Neurology Analyst at GlobalData, comments: “Tavapadon has displayed efficacy and tolerability both as a monotherapy and as an adjunctive therapy. In a phase III trial, patients treated with tavapadon alongside levodopa experienced a significant increase in total “ON” time without troublesome dyskinesia compared to those treated with Levodopa and placebo, highlighting tavapadon’s versatility and use potential in different clinical scenarios.”
The positive results for tavapadon in this pivotal study align with the sentiments of key opinion leaders (KOLs) recently interviewed by GlobalData, who held largely positive opinions on the drug. KOLs frequently cited the promising efficacy data of tavapadon and its unique position as a D1/D5 partial agonist. Furthermore, KOLs stated that tavapadon could be used for dyskinesia, as well as both as a monotherapy in early PD and as an adjunctive therapy in advanced PD.
Opdenakker continues: “There is concern over tavapadon’s market positioning, despite its unique stimulation profile. As a dopamine agonist, it would be entering a crowded market space within the PD treatment landscape and would face fierce competition from several cheaper genericised marketed in-class agents.”
There are six dopamine agonists currently available across the seven major pharmaceutical markets (the US, France, Germany, Italy, Spain, the UK, and Japan), several of which are available as generics, with two additional assets (AbbVie’s tavapadon and IRLAB Therapeutic’s mesdopetam) in the late-stage pipeline (Phases IIb–III).
Tavapadon has displayed efficacy and tolerability both as a monotherapy and as an adjunctive therapy. In a phase III trial, patients treated with tavapadon alongside levodopa experienced a significant increase in total “ON” time without troublesome dyskinesia compared to those treated with Levodopa and placebo.
GlobalData expects tavapadon to enter the market in 2028, and despite its impressive efficacy data, the drug’s success will likely be influenced by its safety profile. KOLs have noted that dopamine agonists are no longer the preferred adjunctive therapies for PD due to the risk of side effects such as hallucinations, delusions, and compulsive behavior. Tavapadon may become a success in the dopamine agonist market as a result of its improved safety profile coupled with strong efficacy data.
