apomorphine SC (ND0701) / Tanabe Pharma - LARVOL DELTA

The Future of Parkinson Disease Therapies and the Challenges With Stem Cell Therapies (NeurologyLive) - "In a presentation at the 2022 ATMRD Congress, Rajesh Pahwa, MD, FANA, FAAN, spoke about the hope held for stem cell approaches and the potential to improve care with several therapies with possible approvals on the horizon....'If I were to predict, I would say the next four of them would definitely be in the market in the next 3 to 4 years,' Pahwa said."

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Treating Morning OFF Episodes in Parkinson’s Disease - Episode 5: Parkinson Disease: SL Apomorphine Hydrochloride for Morning OFF Episodes (NeurologyLive) - "Peter A. LeWitt, MD: Apomorphine is a dopaminergic agonist that, in addition to being given subcutaneously, can also be given sublingually in a strip that is rapidly absorbed through the mucosa of the mouth and going into the circulation to treat Parkinsonian symptoms. Like the injected form, apomorphine has an optimal dose for many patients, and several different dose strips are available so that a patient can determine for themselves whether adverse effects would occur or whether they get optimal effect. Patients typically are asked to start with the lowest dose and build up gradually in repeated trials as to whether a particular dose is giving them the effect they want without adverse effects."

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Episode 2: Apomorphine Subcutaneous Injection: Historical Perspective for Off-Episodes in Parkinson’s Disease (NeurologyLive) - "Daniel E. Kremens, MD, JD: We've had a lot of recent approvals and some data. Let's look at some treatment options, starting with some dopamine agonist options. Let's discuss how you think about the following dopamine agonists that have been approved or are in development to treat off-episodes. Let's talk about 3 different apomorphine products, their method of action, and delivery system advantages....Rajeev Kumar, MD: I started using Apokyn [apomorphine hydrochloride] when I was a fellow in the early 1990s. We used it extensively just prior to the beginning of device-aided therapy with deep-brain stimulation. We had lots of patients who had severe unpredictable off-episodes. They had PD for 10, 15, 20, or more years. We could not administer levodopa frequently enough or productively enough, and using Apokyn [apomorphine hydrochloride] was a tremendous advantage. We used it because it kicks in very quickly, as we'll talk about in just a moment, and very predictably."

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ND0701, A Novel Formulation of Apomorphine for Subcutaneous Infusion, in Comparison to a Commercial Apomorphine Formulation: 28-Day Pharmacokinetic Study in Minipigs and a Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Relative Bioavailability. (PubMed, CNS Drugs) - "Based on these pilot studies, ND0701 appears to be superior to APO-go in terms of tolerability and safety, while maintaining comparable bioavailability with APO-go, and shows promise as a future treatment for PD."

Clinical • Journal • M&A • P1 data • PK/PD data