#xanomeline/trospium chloride

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New Antipsychotic FDA Approval – Cobenfy

Cobenfy (xanomeline/trospium chloride) has just been approved for schizophrenia treatment in the US. This is huge. It's the first antipsychotic in decades to not target dopamine directly. It's got a much, much better side-effect profile, and it might work for negative and cognitive symptoms.

FOR MORE READING – news report/patient-centred plain language overview: See here.

FOR MORE READING – scientific evidence report: See here (note: the drug is referred to as 'KarXT' in this report).

I couldn't be happier right now. People with psychosis go through so, so much trying to find medications that are both useful and tolerable, and psychiatry has historically neglected psychotic people's needs so, so awfully. (Not to mention how little there is that actually helps with anything other than positive symptoms.) So I'm really, really hoping that with the proof that we can, in fact, make antipsychotics that aren't based on the same old pharmacological things we've tried before. Cobenfy is a muscarinic agonist/antagonist in fixed combination – and it also indirectly regulates dopamine and glutamate. And given that we know both dopamine and NMDA are probably involved in schizophrenia somehow – AND that treating things to do with either is hard – this is so, so, so exciting.

This isn't to say Cobenfy doesn't have side-effects (the most common ones being nausea, constipation, dyspepsia, vomiting, hypertension, dry mouth, and tachycardia. We also know that there is a small risk of extrapyramidal symptoms, and that prolactin-related side-effects do happen, unfortunately). We don't know much about how it affects folks in the long-term, or much about the long-term tardive dyskinesia risk. But even so, it's progress compared to some of the worse antipsychotic side-effects.

Moreover, there is a possibility it might be useful for negative and cognitive symptoms. Holy crap.

I'm really really really excited. I hope this is the start of a shift in psychiatry towards better standards of patient-centred care for psychosis. Y'all have deserved better for far too long – here's hoping this is the start of more ethical, effective treatment.

[ryjelsum]

slightly educated pharmacology news

a new medication was just approved by the FDA for usage in the USA for schizophrenia (and i'm presuming it'll be used for psychosis in general) and it is actually something of a big deal because it works fundamentally differently from other schizophrenia/psychosis medication, it doesn't work by fucking your dopamine. so if doctors want to prescribe you traditional antipsychotics and you already know those don't work well for you but you still want to try meds, maybe redirect them to this after doing a little bit of research or waiting a little bit for firsthand reports

it's 'xanomeline & trospium chloride', brand name 'cobenfy'. from what i gather this is one of those medications where another medication is tacked on to deal with significant side effects from the actually functional medication

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Thanksgiving Small Bits & Pieces

I’m going to kick off this Doc Gumshoe missive with a bit of definitely good news, albeit news that is not likely to affect many citizens of Gumshoe Nation. In a nutshell, it is this: on September 26th, the FDA approved the first new drug to treat schizophrenia in more than 30 years. The drug is Cobenfy (xanomeline/trospium chloride, a fixed-dose combination medication. It was initially developed…

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Karuna raises $68m to develop neurology drug KarXT

Karuna Therapeutics has raised $68 million to further develop its neurology drug KarXT, which is in phase 2 clinical development for acute psychosis in patients with schizophrenia.

Formerly known as Karuna Pharmaceuticals, the company is an affiliate of US-based PureTech Health, and will use funding to develop KarXT into additional indications.

The $68 million Series B funding round includes investment from ARCH Venture Partners, with participation from Fidelity Management & Research Company, Eventide Asset Management, Pivotal bioVenture Partners, Partner Fund Management, Wellcome Trust, Sands Capital, Alexandria Venture Investments, and founder PureTech Health.

Karuna wants to develop KarXT, a combination of novel muscarinic acetylcholine receptor agonist xanomeline, and the FDA-approved muscarinic receptor antagonist trospium chloride, which has been shown not to enter the central nervous system.

KarXT is designed to preferentially target M1/M4 muscarinic receptors in the brain while inhibiting their stimulation in peripheral tissues to significantly improve tolerability.

A pair of phase 1 clinical trials have demonstrated a clinically meaningful reduction in side effects compared to xanomeline and demonstrated that KarXT is well tolerated in healthy volunteers.

KarXT is currently being evaluated in a phase 2 clinical trial as a potential treatment for acute psychosis in patients with schizophrenia. Proceeds from the financing will be used to advance the development of KarXT into several new indications, including geriatric psychosis and pain, progress new formulations of KarXT, expand the pipeline, and continue to build company infrastructure.

A proprietary co-formulation of xanomeline and trospium in a single capsule was used in the second phase 1 clinical trial and is now being evaluated in the ongoing phase 2 clinical trial in patients with schizophrenia experiencing acute psychosis.

Top-line data from this trial are anticipated by the end of 2019. A Phase 1b experimental pain trial in healthy volunteers and clinical work towards geriatric psychosis are expected to begin later this year.

The post Karuna raises $68m to develop neurology drug KarXT appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/karuna-raises-68m-to-develop-neurology-drug-karxt/

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Steve Paul reignites xanomeline research as Karuna CEO

Steve Paul has been appointed CEO of US biotech Karuna, to lead development of the psychiatric drug xanomeline, a previously shelved project that he helped to develop at Eli Lilly in the 1990s.

Paul spent 17 years at Eli Lilly, where he held roles including executive vice president for science and technology, and president of Lilly Research Laboratories.

At Lilly, Paul helped develop the company’s mental health blockbusters, Zyprexa and Cymbalta, and helped oversee development of muscarinic cholinergic receptor agonist xanomeline, where its antipsychotic and precognitive properties were first demonstrated.

Karuna hopes that by combining xanomeline with trospium chloride, the safety concerns that caused the drug to be dropped will be overcome.

Paul was previously chairman at Karuna, but has decided to take the job as CEO after the company completed a $42 million funding round including investment from ARCH Venture Partners, the Wellcome Trust and PureTech Health.

Meanwhile Karuna’s founder Andrew Miller is moving to a new post as chief operating officer of the biotech.

Proceeds of the fundraiser will be used to advanced the lead product, now dubbed KarXT (Karuna-xanomeline-trospium chloride).

This includes a phase 2 trial in schizophrenia patients in the third quarter of 2018, and expansion into other therapeutic areas such as Alzheimer’s and pain.

With his appointment Paul brings more than three decades of neuroscience and central nervous system expertise to Karuna.

He is also a co-founder and board member of Sage Therapeutics, and a co-founder of Voyager Therapeutics.

Steve Paul

Paul said: “Targeting muscarinic receptors is one of the most promising approaches to treating both the psychosis and cognitive impairment that characterise many disabling neuropsychiatric disorders, including schizophrenia and Alzheimer’s disease, where there is a profound need for more effective treatments.

“Having been one of the scientists involved in the original work on xanomeline at Lilly, I am excited by the progress that Karuna has made to unlock this important new class of therapeutics.

“I am looking forward to helping Karuna become a leader in the field and believe in the potential for KarXT to be the first antipsychotic drug with a truly novel mechanism in over 60 years. We are also excited by recent preclinical work suggesting that KarXT may be an effective non-opiate treatment for pain.”

The post Steve Paul reignites xanomeline research as Karuna CEO appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/steve-paul-reignites-xanomeline-research/