Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL - LARVOL DELTA

Sublingual apomorphine for Parkinsonian tremor: a post-hoc analysis of pivotal trial data. (PubMed, J Neural Transm (Vienna)) - P3 | "This post‑hoc analysis evaluated tremor outcomes associated with apomorphine sublingual film (SL‑APO) in patients with a tremor‑dominant PD phenotype, using data from a 12‑week randomised, double‑blind, placebo‑controlled trial (NCT02469090) and a 12‑month open‑label study (NCT02542696) conducted in levodopa‑responsive patients with OFF episodes...In the open‑label study, tremor reductions of 31-37% were maintained over 12 months, with responder rates remaining above 70%. These exploratory findings in a small subgroup are consistent with a potential for early and maintained tremor improvement with SL‑APO in patients with tremor‑dominant PD; however, the results are hypothesis‑generating and require prospective confirmation."

Journal • Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease

Safety, tolerability and pharmacokinetics (PK) study of NT-301 nano-apomorphine freebase as a single use nasal spray (WPC 2026) - "An APO-HCl sublingual film (KYNMOBI®), was approved by the FDA and Health Canada but later withdrawn...A randomized, double-blind, placebo-controlled Phase 1 study was conducted in Australia to evaluate the safety, tolerability, and PK of single ascending doses of NT-301following antiemetic prophylaxis with domperidone...NT-301 was generally well tolerated, with no clinically significant adverse events reported. A single instance of mild, transient nasal irritation was observed among 39 NT-301 administrations."

Clinical • Late-breaking abstract • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease

Bial launches new sublingual Parkinson’s treatment in UK (PharmaTimes) - "The sublingual film avoids first-pass metabolism and is designed to deliver rapid symptom relief. Its efficacy and safety were demonstrated in two phase 3 studies, including a double-blind placebo-controlled trial and an open-label crossover study comparing it with subcutaneous apomorphine."

Launch non-US • Parkinson's Disease

Apomorphine Sublingual Film's Efficacy in Elderly Patients with Parkinson's Disease: Post-hoc Analysis of Study CTH-301 (MDS Congress 2025) - "SL-APO was efficacious over the long-term as an on-demand treatment for OFF episodes in elderly patients with PD. Figure 1. Figure 2."

Clinical • Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease

Apomorphine sublingual film's efficacy in elderly patients with Parkinson's disease: Post-hoc analysis of study CTH-301 (EAN 2025) - "SL-APO was efficacious over the long-term as an on-demand treatment for OFF episodes in elderly patients with PD."

Clinical • Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease

SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment (clinicaltrials.gov) - P=N/A | N=90 | Recruiting | Sponsor: Bial - Portela C S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • HEOR • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment (clinicaltrials.gov) - P=N/A | N=90 | Not yet recruiting | Sponsor: Bial - Portela C S.A.

HEOR • New trial • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

Insights into retention and safety/tolerability of apomorphine sublingual film in patients with Parkinson's disease and OFF episodes: post hoc analyses of a phase III, open-label study. (PubMed, Ther Adv Neurol Disord) - "Such events were mostly mild or moderate, occurring within the first months after SL-APO initiation, and generally resolved, with worsening being rare. These analyses provided insights into retention and safety/tolerability of SL-APO, helping clinicians and patients make informed treatment decisions."

Journal • P3 data • Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease

Safety and Efficacy of Sublingual Apomorphine in Parkinson's Patients with or without Concomitant Dopamine Agonists Use (MDS Congress 2024) - "Objective: This post-hoc analysis of Study CTH-301 aimed to assess the safety and efficacy of apomorphine sublingual film (SL-APO) in patients with Parkinson's disease with or without concurrent dopamine agonists (DA) use at baseline... While SL-APO was found to be better tolerated in DA users, it demonstrated efficacy in both DA and non-DA users."

Clinical • CNS Disorders • Parkinson's Disease

Oropharyngeal Adverse Events in Parkinson's Patients with Motor Fluctuations Treated with Apomorphine Sublingual Film (MDS Congress 2024) - "Oropharyngeal TEAEs, including those leading to discontinuation, were mostly mild or moderate and predominantly occurred within the first few months of SL-APO initiation."

Adverse events • Clinical • CNS Disorders • Parkinson's Disease

Baseline Variables Associated with Apomorphine Sublingual Film Retention (MDS Congress 2024) - "Levodopa dose and intakes, morning akinesia, previous SL-APO exposure and concomitant dopamine agonists use might influence retention. These results may help identify patients more likely to remain on SL-APO over the long term."

CNS Disorders • Parkinson's Disease

Oropharyngeal adverse events in Parkinson’s patients with motor fluctuations treated with apomorphine sublingual film (EAN 2024) - "Oropharyngeal TEAEs, including those leading to discontinuation, were mostly mild or moderate and predominantly occurred within the first few months of SL-APO initiation."

Adverse events • Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Safety and efficacy of sublingual apomorphine in Parkinson’s patients with or without concomitant dopamine agonists use (EAN 2024) - "Background and Aims: In Study CTH- 301, apomorphine sublingual film (SL- APO) was generally well tolerated and efficacious over the long term as treatment for OFF- episodes in patients with Parkinson ' s disease... While SL- APO was found to be better tolerated in DA users, it demonstrated efficacy in both DA and non- DA users."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Baseline variables associated with apomorphine sublingual film retention (EAN 2024) - "Levodopa dose and intakes, morning akinesia, previous SL-APO exposure and concomitant dopamine agonist use might influence retention. These results may help identify patients more likely to remain on SL-APO over the long term."

CNS Disorders • Movement Disorders • Parkinson's Disease

Clinical trial evaluating apomorphine oromucosal solution in Parkinson's disease patients. (PubMed, Clin Transl Sci) - "This two-part clinical study evaluated the safety, tolerability, pharmacokinetics (PK), and dose proportionality of a novel apomorphine hydrochloride oromucosal solution, as well as its relative bioavailability to subcutaneous apomorphine injection and apomorphine sublingual film...This was comparable to exposure reached after 2 mg subcutaneous apomorphine and approximately half of the exposure observed with 30 mg sublingual apomorphine. In summary, clinically relevant plasma concentrations could be reached in PD patients without tolerability issues."

Clinical • Journal • CNS Disorders • Fatigue • Hypotension • Movement Disorders • Parkinson's Disease

Long-term safety, tolerability and efficacy of apomorphine sublingual film in patients with Parkinson's disease complicated by OFF episodes: a phase 3, open-label study. (PubMed, J Neurol) - P3 | "SL-APO was generally well tolerated and efficacious over the long term as an on-demand treatment for OFF episodes in patients with PD."

Journal • P3 data • CNS Disorders • Dental Disorders • Dermatology • Movement Disorders • Parkinson's Disease • Stomatitis

Apomorphine Sublingual Film Compared with Subcutaneous Apomorphine for OFF Episodes in Parkinson's Disease: An Open-Label, Randomized, Crossover Study. (PubMed, J Parkinsons Dis) - "Patients reported overall preference for and greater satisfaction with SL-APO over SC-APO."

Journal • CNS Disorders • Depression • Movement Disorders • Parkinson's Disease • Psychiatry

Feasibility of home dose optimization of apomorphine sublingual film in Parkinson's disease patients with OFF episodes: results from the dose-optimization phase of an open-label, randomized crossover study. (PubMed, Ther Adv Neurol Disord) - P3 | "After the first clinic dose, home dose optimization of SL-APO appears feasible in patients with PD and OFF episodes, with most patients identifying their optimal SL-APO dose at home. This study is registered with EudraCT (2016-003456-7): Clinical Trials register - Search for eudract_number:2016-003456-70."

Journal • CNS Disorders • Fatigue • Movement Disorders • Parkinson's Disease

Clinic versus home dose optimization of apomorphine sublingual film in Parkinson’s Disease: cross- study comparison of safety (MDS Congress 2023) - "After initiation in clinic, data from the pivotal and crossover studies suggest that the safety profile of SL-APO home dose optimization is comparable to clinic dose optimization."

Clinical • CNS Disorders • Parkinson's Disease

Apomorphine sublingual film for OFF episodes in PD: Impact on orthostatic hypotension during dose-optimization (MDS Congress 2023) - "Overall, SL-APO did not affect general BP readings nor the frequency of OH as assessed by those readings during dose-optimization at in-clinic visits (co-occurring with or without reported OH-related TEAEs)."

CNS Disorders • Parkinson's Disease

Importance of time to ON versus wearing OFF in total daily OFF time experienced by patients with Parkinson's disease. (PubMed, Parkinsonism Relat Disord) - "Hence, most treatment regimens focus on reducing wearing OFF by changing LD dosing/formulations and/or using "ON-extenders" (eg, catechol-o-methyltransferase inhibitors, monoamine oxidase-B inhibitors, extended-release amantadine, and adenosine A receptor antagonists). However, the literature describing approved treatments for PD that has focused on delays in time to ON is sparse and suggests this type of OFF may comprise more than twice the amount of total daily OFF time as wearing OFF. Here, we advocate for the importance of measuring and adequately addressing delays in time to ON and build support for the consistent inclusion of the time to ON measurement in future clinical trials."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Apomorphine Sublingual Film for OFF episodes in PD: Impact on Orthostatic Hypotension during Dose-Optimization (EAN 2023) - "Overall, SL-APO did not affect general BP readings nor the frequency of OH as assessed by those readings during dose-optimization at in-clinic visits (co-occurring with or without reported OH-related AEs). 1. Olanow et al., Lancet Neurol."

CNS Disorders • Hypotension • Movement Disorders • Parkinson's Disease

Kynmobi to be discontinued in US and Canada due to limited use (BioNews) - "Kynmobi (apomorphine hydrochloride), an under-the-tongue therapy approved to help manage off episodes in Parkinson’s disease, is being discontinued in the U.S. as of June 30....Kynmobi is also expected be discontinued in Canada by Sept. 30, according to Drug Shortages Canada. The announcement comes just a few months after Sunovion closed its patient support program for the therapy, called Kynmobi Kynnect. The program ended at the end of 2022, stated a letter sent to healthcare providers."

Discontinued • CNS Disorders • Parkinson's Disease

Dose Optimization of Apomorphine Sublingual Film for OFF Episodes in Parkinson's Disease: Is the Prophylactic Use of an Antiemetic Necessary? (PubMed, J Parkinsons Dis) - "Prophylactic treatment with an antiemetic is not necessary for most patients who initiate SL-APO for the treatment of OFF episodes in PD."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Sumitomo Pharma : Jan. 31, 2023 Q3 FY2022 Conference Call transcript (Market Screener) - "Other non-recurring items include a JPY56 billion impairment loss on the patent rights for KYNMOBI® and other assets recorded in Q2."

Commercial • CNS Disorders • Parkinson's Disease