Foscarbidopa/foslevodopa, in development by AbbVie, is a novel reformulation of the gold-standard Parkinson’s disease treatment (carbidopa/levodopa) delivered via a subcutaneous pump for the treatment of motor fluctuations in advanced Parkinson’s disease. In addition to serving a niche group of patients with high unmet need, it offers better efficacy than orally administered carbidopa-levodopa, dosing flexibility and a more convenient pump than existing and upcoming competitors, and it is backed by AbbVie’s experience in this space via its own DUOPA™/DUODOPA® (carbidopa/levodopa enteral suspension).

About foscarbidopa/

  1. AbbVie
  2. Carbidopa and levodopa prodrugs
  3. Continuous 24-hour subcutaneous infusion to treat motor fluctuations in patients with advanced Parkinson’s disease
  4. 2.8 million diagnosed prevalent cases of Parkinson’s disease in the G7 markets in 2021

Why is it a drug to watch?

If launched when predicted, foscarbidopa/foslevodopa will be the first subcutaneous carbidopa/levodopa infusion to market, addressing noted shortcomings with DUOPA/DUODOPA (e.g., surgical requirements, complications). Although many current treatment options manage motor fluctuations of Parkinson’s disease, patients with advanced Parksinon’s disease often achieve poor motor control, even with chronic polypharmacy. By stabilizing levodopa levels, AbbVie’s pump will offer a more effective alternative for the right patients.

  1. A randomized, controlled phase 3 trial showed:
    • an increase in “on” time of almost three hours compared with oral carbidopa-levodopa, as early as one week into the study, and
    • a decrease in “off” time by a similar magnitude.
  2. A single-arm, phase 3 trial showed:
    • an increase in “on” time of approximately three and a half hours and
    • a decrease in participants with morning akinesia from 77.7% to 19.4%.
  3. Ongoing phase 3 extension trials are further testing long-term safety and tolerability.

Review and approval status

May 2022:
• New Drug Application (NDA) submission: U.S. Food and Drug Administration (FDA)

Expected launch:
2023: United States, Europe and Japan

Patents estimated to expire beginning in 2039

How will foscarbidopa/foslevodopa impact the market for Parkinson’s disease?

  1. Experts are enthusiastic about delivering levodopa-carbidopa via subcutaneous infusion.
  2. The ability to offer multiple dose strengths at one insertion site might prove a strong advantage for foscarbidopa/foslevodopa over the ND0612 pump by NeuroDerm Ltd (a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation), which offers only one strength and requires two insertion sites.
  3. Foscarbidopa/foslevodopa will most likely be prescribed to intermediate and advanced-stage patients with motor fluctuations despite four or more daily doses of oral levodopa-carbidopa (plus one or more levodopa-adjunct therapies).
  4. It will compete primarily with other invasive therapies (i.e., DUOPA/DUODOPA, ND0612, SPN-830 by Supernus Pharmaceutical Inc, Lecigon® by STADA and Lobsor Pharmaceutical, deep brain stimulation [DBS]) in advanced Parkinson’s disease and may compete with longer-lasting oral levodopa reformulations and levodopa-adjunct therapies in uncontrolled intermediate-stage disease with a high pill burden.
  5. DBS is expected to remain a treatment of choice for advanced disease in younger patients, but foscarbidopa/foslevodopa could be an alternative for patients ineligible for DBS or who do not want to undergo surgery.
  6. Efficacy, side effects and cost, as well as the convenience, size and dosing flexibility of competing pumps, will play important roles in treatment selection in advanced Parkinson’s disease.
  7. Expected high pricing could drive blockbuster peak sales despite focused adoption.

What gaps in treatment does foscarbidopa/foslevodopa fill?

Fluctuations in motor function (“on/off” periods) progressively worsen for most patients with Parkinson’s disease until they are no longer effectively managed by available levodopa formulations and adjunctive therapies. These fluctuations impact the patient’s ability to perform activities of daily living as well as quality of life for both patient and caregiver. With its continuous delivery, foscarbidopa/foslevodopa optimizes the pharmacokinetic/pharmacodynamic (PK/PD) profile of the standard of care, which may deliver profound relief for patients with Parkinson’s disease, especially those in the later stages of the disease.

What hurdles might it need to overcome to reach blockbuster status?

Although it will be first to market, foscarbidopa/foslevodopa will compete with other subcutaneous pump options, most notably that by NeuroDerm Ltd expected to launch in mid-2024, and expected high pricing is likely to constrain access and uptake. Also of concern is the high rates of discontinuation of foscarbidopa/foslevodopa reported in completed phase 3 trials.

expected sales in 2027
probability of success for
foscarbidopa/foslevodopa in the United States.

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