KYNMOBI (apomorphine hydrochloride) sublingual film, a novel formulation of apomorphine, a dopamine agonist, is the first and only sublingual therapy for the fast-acting, on-demand treatment of OFF episodes associated with Parkinson's disease. (pipelinereview.com)
KYNMOBI TM (apomorphine hydrochloride) sublingual film is a prescription medicine used to treat short-term (acute), intermittent "off" episodes in people with Parkinson's disease (PD). (pipelinereview.com)
The patients were treated for a period of 14 days and received either capsules containing lactose (placebo) or 20 mg apomorphine hydrochloride in lactose. (inter-zone.org)
Apomorphine Hydrochloride Hemihydrate is a powerful emetic and has been used for that effect in acute poisoning. (pharmaffiliates.com)
The Company successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. (traderpower.com)
Dopamine3
A variety of oral erectogenic agents are available or are in late-phase development, including centrally active dopamine agonists (e.g., sublingual apomorphine), peripheral nonselective alpha-blockers (e.g., oral phentolamine), and other phosphodiesterase type-5 inhibitors (e.g., vardenafil). (biopsychiatry.com)
Apomorphine , a dopamine agonist, has been used for 75 years in small non-emetic doses to treat the acute alcohol intoxication phase of chronic alcoholism. (inter-zone.org)
17. Sexual activity.77 morphine also prevents apomorphine-, 6-ht-2c receptors or the effects of dopamine in response to endothelin 36. (ben.edu)
Sublingual formulation of apomorphine1
With the deal, Sunovion would acquire Cynapsus' then-Phase III Parkinson's disease candidate drug APL-130277, a sublingual formulation of apomorphine. (wikipedia.org)
Infusion3
Treatment with APO-go ® /MOVAPO ® (apomorphine) subcutaneous infusion for 12 weeks gave significantly greater reductions in OFF time (periods when PD medications don't work) from baseline compared with placebo: -2.47 h/day versus -0.58 h/day, respectively - a treatment difference of almost 2 hours (p=0.0025) and double the change in OFF time recognised as meaningful to PD patients. (acnr.co.uk)
Apomorphine infusion is effective and well tolerated by patients experiencing debilitating treatment response fluctuations despite optimised treatment. (acnr.co.uk)
We hope the positive results of the TOLEDO study will help ensure apomorphine infusion, which is delivered using a small, ambulatory mini-pump, is incorporated into national PD treatment guidelines. (acnr.co.uk)
Parkinson's6
MARLBOROUGH, MA, USA I May 21, 2020 I Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has approved KYNMOBI™ (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD). (pipelinereview.com)
Phase 3 clinical trial results, published in Lancet Neurology , demonstrated that patients with PD receiving KYNMOBI experienced significant improvements in motor symptoms at 30 minutes after dosing at week 12, with a mean reduction of 7.6 points, compared to placebo, on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. (pipelinereview.com)
Cyna Pharma was a Canada-based specialty pharmaceutical company that was at the point of conducting Phase 3 clinical trials in 2016 for its main product: APL-130277 - a novel delivery mechanism for an existing drug called apomorphine, used for on-demand treatment of the debilitating off-episodes (freezing) associated with Parkinson's disease (PD). (imd.org)
The case provides an overview of Anthony's unique background, the off-episodes associated with Parkinson's disease, the specialty biopharma sector, the funding rounds to get to Phase 3 clinical trials and the brushes with disaster along the way. (imd.org)
TORONTO, June 30, 2016 - Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize APL-130277, a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson's disease (PD), announced today that the last patient has been enrolled in its pivotal Phase 3 efficacy study, CTH-300. (traderpower.com)
Bhidayasiri R, Boonpang K, Jitkritsadakul O Understanding the role of the Parkinson's disease nurse specialist in the delivery of apomorphine therapy. (britishjournalofcommunitynursing.com)
Formulation2
A new sublingual formulation, APL-130277, by a Canadian drugmaker has now completed early open-label phase IIa testing and results are available (Hauser et al. (neuro-sens.com)
Conclusion: This was the first study of a new sublingual apomorphine formulation in PD patients. (barrowneuro.org)
Apokyn1
Dysport ® (Botulinum toxin type A, 500U, for the treatment of dystonias, spasticity and cosmetic uses), Somatuline ® Autogel ® (lanreotide for the treatment of acromegaly and neuroendocrine tumors), Apokyn ® (apomorphine for the treatment of the syndrome. (pharmaboardroom.com)
Acute3
Report from the 1st Congress of the European Academy of Neurology, Berlin, Germany, June 20-23, 2015 - Subcutaneous apomorphine is clinically available in many countries for the acute treatment of Off periods in PD. (neuro-sens.com)
Sublingual Apomorphine (APL-130277) for the Acute Conversion of off to" by Robert A. Hauser, C. Warren Olanow et al. (barrowneuro.org)
Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. (traderpower.com)
20211
Preclinical and development activities are ongoing, with the initiation of the Phase II clinical program in patients with treatment-resistant depression targeted for the second half of 2021. (supernus.com)
20162
Dose titration phase results from this study are expected in mid to late July and top-line data are expected to be released near the end of the third quarter of 2016. (traderpower.com)
Cynapsus' Phase 3 clinical program for APL-130277 plans to rely on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the company intends to submit an NDA near the end of 2016 or in early 2017. (traderpower.com)
Tolerability1
Annovis Bio is currently running a Phase III trial evaluating the safety, efficacy and tolerability of its pipeline DMT buntanetap tartrate (NCT05357989). (clinicaltrialsarena.com)
Efficacy1
LT-002 is a voluntary Phase 4 15-year ongoing follow-up safety and efficacy study of Zolgensma IV and investigational intrathecal (IT) OAV101 in patients previously treated in the Phase 3 IV studies (STR1VE-US, STR1VE-EU, STR1VE-AP, SPR1NT) and the Phase 1 IT study (STRONG). (medicalresearch.com)
Patients5
Lal and Schlatter [4] reported that apomorphine decreased the craving for alcohol when administered to hospitalized patients and recently Buus et al. (inter-zone.org)
LT001 is a 15-year ongoing observational LTFU study following the Phase 1 START patients, who were the very first patients to receive our gene replacement therapy. (medicalresearch.com)
Recruitment has resumed in the Phase III program in adult patients, after being put on hold in March 2020 due to the impact of the COVID-19 pandemic. (supernus.com)
As of the year 2000, Phase III trials are currently in progress, involving 3300 patients. (bionity.com)
Numerous studies have used apomorphine (APO) in the evaluation of dopaminergic (DA) function in schizophrenic patients. (mdpi.com)
Treatment6
The Foundation supported early clinical development of sublingual apomorphine, and this approval brings an important new treatment option for people with PD who experience OFF. (pipelinereview.com)
However, novel therapies which are in Phase II and III trials are looking to tackle some of these 'vacuums' including treatment of motor symptoms. (clinicaltrialsarena.com)
In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. (mayo.edu)
Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market. (mayo.edu)
[ 77 ] Treatment with sustained-release bupropion proved effective in a phase II, randomized, double-blind, parallel-group, placebo-controlled trial involving 80 men with sexual dysfunction that emerged during methadone maintenance therapy. (medscape.com)
Behavior2
Iloperidone has also been shown to reduce the effects of apomorphine induced climbing behavior in mice as well as the effects of head twitching induced by 5-HT in rats. (bionity.com)
Furthermore, IP-LGF decreases apomorphine-induced rotational behavior and boosts engine peformace in these pets. (antiviralbiologic.com)
Psychosis1
Psychosis induced using PCP, apomorphine, and cirazoline, were all prevented with the concurrent administration of iloperidone. (bionity.com)
Neurology1
Britannia Pharmaceuticals Ltd has announced publication of the results of the double-blind phase of the TOLEDO study in Lancet Neurology 1 . (acnr.co.uk)
Dopaminergic2
The dopaminergic system could also play a role in the headache phase, either by taking part in nociception mechanisms, or by regulating cerebral blood flow. (baillement.com)
Apomorphine administration induces in migraineurs more yawns as well other dopaminergic symptoms e.g. yawning, nausea, vomiting, dizziness. (baillement.com)
Study6
The TOLEDO study is sponsored by Britannia Pharmaceuticals Ltd., part of the STADA Arzneimittel AG group of companies and manufacturer of apomorphine products. (acnr.co.uk)
In a double-blind study in chronic alcoholics apomorphine was shown to have a significant effect on alcoholic crax g and on tension. (inter-zone.org)
1] found in a double-blind study that a group of alcoholics were statistically significantly more sober the day after apomorphine administration than a similar group receiving chlordiazepoxide or placebo. (inter-zone.org)
Apomorphine is a difficult drug to study. (inter-zone.org)
Methods: The authors conducted a phase 2, open-label, proof-of-concept study. (barrowneuro.org)
Sildenafil1
Eli Lilly, Indianapolis, IN, USA), both of which are phosphodiesterase-5 (PDE5) inhibitors, are currently in Phase III clinical trials and could prove more potent, and produce fewer side effects, than sildenafil. (health.am)
Prove1
On the other hand variations of apomorphine may prove extremely effective in controlling the withdrawal syndrome. (erowid.org)
Significantly1
In the second experiment, the frequency of seizures in the model's chronic phase did not significantly change between groups. (scielo.br)
Trials4
Phase II clinical trials data have continued to show promise for vardenafil. (health.am)
Increased expenses were partially offset by reduced spending for the SPN-810 Phase III trials. (supernus.com)
Phase 3 trials include large numbers of people to make sure that the result is valid. (mayo.edu)
Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. (mayo.edu)
Administration1
Subjects were evaluated in the pre-dose morning Off state and at 15, 30, 45, 60 and 90 minutes after administration of sublingual apomorphine. (neuro-sens.com)
Humans1
Phase II testing has shown that effectiveness in humans is possible with as low as 8mg per day, and is tolerable up to 32mg per day. (bionity.com)
Effects1
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. (mayo.edu)
Chronic3
In broad clinical experience we have found that capsules of 20 mg apomorphine in lactose seem to be a good sedative for chronic alcoholics. (inter-zone.org)
In general terms, epileptic discharge, seizure-like behaviors in the chronic phase of Pilocarpine experimental model, sudden unexpected death in epilepsy and consequently epileptic seizures have been associated with an imbalance between excitation and inhibition in specific brain circuitries ( Bozzi and Borrelli, 2013 BOZZI, Y. and BORRELLI, E., 2013. (scielo.br)
Non-Status Epilepticus female rats show seizure-like behaviors in the chronic phase of Pilocarpine experimental model. (scielo.br)
Delivery1
APL-130277 is a "turning ON" medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. (traderpower.com)
Development1
On June 9, 2004, Titan Pharmaceuticals announced that the Phase III development rights have been acquired by Vanda Pharmaceuticals. (bionity.com)
Drug1
Uterine glands these glands but also by concomitant medical con- dition progresses, it gradually develops into three particularly good correlation between diagnostic biopsy method 30 40 years with no donors, min prior to beginning the swing phase, the clitoris and the need ally and morphologically completing maturation and involution of some men as a radioactive cardura cialis drug interaction and iridium wire radioisotope bone scintigraphy and bone 43. (ben.edu)
Trial1
The phase III CTH-300 trial (NCT02469090) enrolled its first patient in June 2015. (neuro-sens.com)