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Abstract Details

Characterization of Infusion Site Reactions (ISR) with 24-hour Subcutaneous Infusion of ND0612: Findings from an Integrated Safety Database
Movement Disorders
P9 - Poster Session 9 (8:00 AM-9:00 AM)
3-010

ND0612 is an investigational, continuous 24h subcutaneous infusion of levodopa/carbidopa (max daily dose 720/90 mg, to be supplemented as needed with oral therapies), delivered via two cannulas (max 6mL per cannula per day) to reduce skin burden. Clinical trial experience indicates that, as expected with the subcutaneous route of administration, local ISRs are common.

Evaluate and characterize infusion site reactions (ISR) reported as a treatment-emergent adverse event (TEAE) with 24h ND0612 treatment in clinical studies.

An integrated safety analysis of ISRs reported as TEAEs in people with PD treated with a 24h regimen of ND0612 from two phase 2 (NCT02577523 and NCT02726386) and one phase 3 (NCT04006210) studies was conducted. Grouped terms were defined for infusion site nodules, hematoma, swelling, eschar, erythema, infection (including abscess and cellulitis), and pain.

A total of 419 patients were included in this analysis with a mean±SD [range] exposure of 395±471 days [2 days to 6.2 years]. Overall, 369 (88%) of patients reported ≥1 ISR as a TEAE, including 15 (4%) patients who reported serious TEAEs. Forty-nine (12%) patients discontinued due to an ISR. Of 2461 reported ISR events, the most reported were: nodules (1065 events, 43%), hematoma (815 events, 33%), pain (141 events, 6%), and infection (134 events, 5%). Most reported ISR TEAEs were mild (2079 events, 85%). Moderate ISR TEAEs accounted for 347 events (14%). Of the 34 (1%) severe ISR events reported, almost half were ISR-infection events (16 events reported in 13 patients). Presumed ISR-infections were mainly managed with oral antibiotics and abscess drainage; median time to resolution was 15 days.

While ISRs were commonly reported as TEAEs, 99% of ISR adverse events were mild or moderate in severity and resolved with or without treatment. Despite the incidence of ISR events, most patients continued in the trials.

Authors/Disclosures
Rajesh Pahwa, MD, FAAN (University of Kansas Medical Center)
PRESENTER
Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbott. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pahwa has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for ACADIA. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allevion. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Insightec. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jaaz. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuroderm. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Photopharmics. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sun Biopharma. The institution of Dr. Pahwa has received research support from Abbott. The institution of Dr. Pahwa has received research support from Abbvie. The institution of Dr. Pahwa has received research support from Biogen. The institution of Dr. Pahwa has received research support from Biohaven. The institution of Dr. Pahwa has received research support from EIP. The institution of Dr. Pahwa has received research support from Amneal. The institution of Dr. Pahwa has received research support from Parkinson Foundation. The institution of Dr. Pahwa has received research support from Roche. The institution of Dr. Pahwa has received research support from Sage. The institution of Dr. Pahwa has received research support from Sun Pharma. The institution of Dr. Pahwa has received research support from Theranexus. The institution of Dr. Pahwa has received research support from Theravance. The institution of Dr. Pahwa has received research support from Voyager. The institution of Dr. Pahwa has received research support from Neuroderm. The institution of Dr. Pahwa has received research support from Annovis. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Blue Rock. The institution of Dr. Pahwa has received research support from Cerevance. The institution of Dr. Pahwa has received research support from Fasikl. The institution of Dr. Pahwa has received research support from Praxis. The institution of Dr. Pahwa has received research support from Scion. The institution of Dr. Pahwa has received research support from UCB.
Aaron Ellenbogen, DO Dr. Ellenbogen has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for allergan. Dr. Ellenbogen has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for allergan. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ipsen. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda.
No disclosure on file