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Juvmo (tavapadon)

Parkinson's disease

Also known as CVL-751
Manufacturer
AbbVie
Regulatory submission
NDA submitted September 2025
Last updated
217 sources

Product information and disease descriptionProduct descriptionProduct information

Contraindications/Warnings/Precautions/Adverse effects

13 evidence topics · 1 source

Warnings and precautions
Summary of warnings and precautions in the prescribing information highlights

“May cause hypotension/orthostatic hypotension. (5.1)” (opens the prescribing information at this quote)

“May cause problems with impulse control or compulsive behaviors. Consider dose reductions or stopping JUVMO. (5.2)” (opens the prescribing information at this quote)

“May cause hallucinations and psychotic-like behavior. The risk of hallucinations may be increased when co-administered with strong CYP3A inhibitors during the maintenance phase. (5.3)” (opens the prescribing information at this quote)

“May cause dyskinesia or exacerbate pre-existing dyskinesia. (5.4)” (opens the prescribing information at this quote)

Contraindications

“CONTRAINDICATIONS None.” (opens the prescribing information at this quote)

Hypotension and orthostatic hypotension

“Patients with PD may have an impaired capacity to respond to an orthostatic challenge. In clinical studies and clinical experience, dopaminergic medications appear to impair the systemic regulation of blood pressure, resulting in hypotension and/or orthostatic hypotension, especially during dose escalation. For these reasons, patients with PD being treated with JUVMO should be monitored for signs and symptoms of hypotension/orthostatic hypotension especially during dose escalation, and should be informed of this risk.” (opens the prescribing information at this quote)

“In Study 1 and Study 2 in patients with PD who were not taking levodopa [see Clinical Studies (14.1)], orthostatic hypotension was reported in 5% of patients treated with JUVMO compared to 1% of patients who received placebo. Hypotension was reported in 4% of patients treated with JUVMO tablets compared to 1% on placebo.” (opens the prescribing information at this quote)

“In Study 3 in patients taking JUVMO as adjunctive therapy to fixed dose levodopa [see Clinical Studies (14.2)], orthostatic hypotension was reported in 8% of patients treated with JUVMO compared to 2% of patients on placebo. Hypotension was reported in 4% of patients treated with JUVMO compared to 0.4% on placebo.” (opens the prescribing information at this quote)

Impulse control and compulsive behaviors

“Patients may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and are generally used for the treatment of PD, including JUVMO.” (opens the prescribing information at this quote)

“In Study 1 and Study 2, impulse control disorders were reported in 1% of patients treated with JUVMO compared to no patients on placebo. In Study 3, impulse control disorders were reported in 2% of patients treated with JUVMO compared to 1% of patients on placebo.” (opens the prescribing information at this quote)

“Consider reducing the dose or discontinuing JUVMO if a patient develops such urges.” (opens the prescribing information at this quote)

Hallucinations and psychotic-like behavior

“In Study 1 and Study 2, hallucination was reported in 3% of patients treated with JUVMO compared to no patients on placebo. In Study 3, when added as an adjunct to a fixed dose of levodopa, hallucination was reported in 7% of patients treated with JUVMO compared to 1% of patients on placebo.” (opens the prescribing information at this quote)

“Age appears to increase the risk of hallucinations in patients taking JUVMO. In Study 1 and Study 2, among patients 65 years of age and older, hallucination was reported in 4% of patients treated with JUVMO compared to no patients on placebo. In Study 3, among patients 65 years of age and older, hallucination was reported in 9% of patients treated with JUVMO compared to 1% of patients on placebo.” (opens the prescribing information at this quote)

“The risk of hallucination may be increased when JUVMO is co-administered with strong CYP3A inhibitors during the maintenance phase [see Dosage and Administration (2.2)].” (opens the prescribing information at this quote)

Drug-disease interaction: major psychotic disorder

“Consider the risks and benefits prior to initiating treatment with JUVMO in patients with a major psychotic disorder because of the risk of exacerbating psychosis. In addition, certain medications used to treat psychosis may exacerbate the symptoms of PD. Consider stopping JUVMO if hallucinations or psychotic-like behaviors occur.” (opens the prescribing information at this quote)

Dyskinesia

“JUVMO may cause or exacerbate pre-existing dyskinesia. In Study 1 and Study 2, 0.6% of patients with PD treated with JUVMO reported dyskinesia compared with no patients on placebo. In Study 3, 10.0% of patients treated with JUVMO reported dyskinesia compared to 2% on placebo. Consider decreasing the dosage of JUVMO or other dopaminergic medications if dyskinesia occurs.” (opens the prescribing information at this quote)

Clinical trial safety database

“The safety of JUVMO was evaluated in 1,279 patients with PD who received at least one dose of JUVMO. Of the patients with PD who received JUVMO, 870 were treated for at least 6 months and 630 were treated for at least 1 year.” (opens the prescribing information at this quote)

Adverse reactions without concomitant levodopa: most common reactions and discontinuations

“In Study 1 and Study 2 combined (n=833 total patients), the most common adverse reactions that occurred in ≥ 5% of patients treated with JUVMO were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety. Adverse reactions led to discontinuation of JUVMO in 100 of 505 patients (20%). Of the 100 patients receiving JUVMO who discontinued because of an adverse reaction, 85 (85%) did so during the titration and/or adjustment phases. The most common adverse reactions leading to discontinuation in patients taking JUVMO were nausea, dizziness, headache, and vomiting.” (opens the prescribing information at this quote)

Adverse reactions in at least 3% of participants and at least 2% more than placebo, Studies 1 and 2 (without concomitant levodopa)
Adverse reactionJuvmo (N=505), %Placebo (N=328), %
Nausea“27”“2”
Headache (multiple related terms)“17”“5”
Dizziness“14”“4”
Fatigue (includes asthenia)“10”“3”
Dysgeusia“8”“0”
Vomiting“7”“<1”
Dry mouth“5”“<1”
Anxiety“5”“2”
Hypotension“4”“1”
Dyspepsia“4”“1”
Abnormal dreams“4”“<1”
Orthostatic hypotension“4”“<1”
Hallucination (multiple related terms)“3”“0”
Gastroesophageal reflux disease“3”“<1”
Constipation“3”“1”
Adverse reactions with concomitant levodopa: most common reactions and discontinuations

“Patients in Study 3 were on a fixed dose of levodopa and were titrated to JUVMO 15 mg once daily unless prevented by intolerance, resulting in maintenance doses between 5 mg and 15 mg (n=251), compared to placebo (n=254). The most common adverse reactions that occurred in ≥ 5% of patients treated with JUVMO were nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension. Adverse reactions led to discontinuation of JUVMO in 43 of 251 patients (17%). Of the 43 patients receiving JUVMO who discontinued because of an adverse reaction, 38 (88%) did so during the titration and adjustment phases. The most common adverse reactions leading to discontinuation included nausea, dyskinesia, visual hallucination, and dizziness.” (opens the prescribing information at this quote)

Adverse reactions in at least 3% of participants and at least 2% more than placebo, Study 3 (with concomitant levodopa)
Adverse reactionJuvmo (N=251), %Placebo (N=254), %
Nausea“14”“4”
Dyskinesia“10”“2”
Dizziness“8”“3”
Headache (multiple related terms)“7”“3”
Hallucination (multiple related terms)“7”“1”
Orthostatic hypotension“6”“1”
Hypotension“4”“<1”
Abdominal pain“3”“<1”
Asthenia“3”“0”
Nonclinical carcinogenicity findings

“In the 26-week study, mice had an increased incidence of hepatocellular adenomas at 100 mg/kg/day. In the 2-year study in rats, female rats exhibited an increase in pancreatic and whole body adenocarcinoma at the high dose 120 mg/kg/day. Tavapadon exposure at this dose was 14-fold greater than the exposure at the MRHD.” (opens the prescribing information at this quote)

“The endocrine mechanism involved in the production of these tumors (prolactin reduction) in rats is not considered relevant to humans.” (opens the prescribing information at this quote)

“Tavapadon was not mutagenic or clastogenic in in vitro (bacterial mutagenicity and micronucleus TK6 cells) and in vivo (rat peripheral blood micronucleus) assays.” (opens the prescribing information at this quote)