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Post by peppy on Jul 19, 2021 14:26:14 GMT -5
Next will be Cannabidiol Technosphere, folks! Receptor Life Sciences Announces Initiation of IND-Opening Clinical PK Study of RLS102 for Irritability in Autism Spectrum DisorderSEATTLE – Receptor Life Sciences (RLS), a pharmaceutical company developing innovative therapies to address central nervous system disorders, announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for RLS102. This first-in-class, pure synthetic CBD capsule is being investigated for the treatment of irritability in patients with autism spectrum disorder. RLS102 is a novel formulation that uses an FDA-approved drug delivery technology. Following the IND acceptance, RLS initiated a pharmacokinetic (PK), formulation selection study using RLS102 in healthy volunteers. The results will be used to identify the formulation for clinical development. The RLS102 capsules contain both pure synthetic cannabidiol (CBD) and SNAC, an FDA-approved oral absorption enhancer. In an initial proof-of-concept clinical study, RLS102 resulted in a 6-fold increase in CBD absorption from the gastrointestinal tract compared to solid oral CBD alone. In addition to improving CBD bioavailability, RLS102 reduces the high variability associated with currently marketed oral CBD products. "RLS102 has the potential to be a new treatment to reduce irritability in patients living with autism spectrum disorder," said Mark Theeuwes, President and CEO, Receptor Life Sciences. "This IND acceptance is an important milestone for Receptor Life Sciences and demonstrates our ability to develop drug products in an FDA-regulated environment. We look forward to moving RLS102 into clinical efficacy studies as quickly as possible." A complex developmental disorder often associated with a high level of irritability, autism spectrum disorder (ASD) affects about 5 million adults in the United States (https://www.cdc.gov/ncbddd/autism/features/adults-living-with-autism-spectrum-disorder.html). No treatments are approved for adults with ASD-associated irritability. www.receptorlife.com/Synthetic, it will be patentable and FDA approved? Will it be prescription? Insurance covered medication? Asking for a friend. Any opinions? |
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Post by sayhey24 on Jul 19, 2021 14:46:44 GMT -5
Mango - this seems like really good news. I agree, TS would be the next step and solves the digestive issues. It would be nice to see it sold over the counter. Synthetic CBD is also interesting going for FDA approval.
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Post by nylefty on Jul 19, 2021 23:48:36 GMT -5
I only know one person with autism, but I think he would be
much more likely to swallow another pill than to successfully
inhale a powder. I could be wrong.
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Post by longliner on Jul 19, 2021 23:50:32 GMT -5
I only know one person with autism, but I think he would be much more likely to swallow a pill than to successfully inhale a powder. I could be wrong. Maybe, but less chance of choking with an inhaler. I have a feeling that this conversation has been thoroughly hashed over, apparently, RLS agree with you. |
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Post by hopingandwilling on Jul 20, 2021 7:07:18 GMT -5
Why is this Receptor news even being discussed on the MNKD board? The PR from Receptor clearly states their proposed drug is a capsule delivery where the drug has been enhanced by using a FDA approved ORAL absorption enhancer.
There is no mention, and why would they mention MNKD and the use of the Technosphere technology- MNKD’s delivery is only designed for use in inhalation dosing.
Maybe I’m missing something—but IMO Receptor is telling us they have moved away from using MNKD’s services and product
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Post by uvula on Jul 20, 2021 7:29:25 GMT -5
If rls dies, mnkd gets no money. If rls stays in business, mnkd has the potential to get money in the future.
Even if rls's first product is not inhaled, it will help rls. If rls stays in business, it keeps the dream of future mnkd royalties alive.
I still think future rls royalties are more likely than future Brazil or India profits.
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Post by akemp3000 on Jul 20, 2021 7:33:49 GMT -5
The history of RLS and their Chief Scientific Office, Andrea Leone-Bay who worked directly for Al Mann and holds patents with inhalation technology, and to the best of my knowledge still has an office in Mannkind's Danbury plant, speaks volumes saying RLS will not be moving away from TS or MNKD's services and products. The recent announcement that RLS wants FDA approval for a capsule using the RLS drug seems to be a fast track opportunity for the first RLS drug approval. IMO, based on RLS history and the existing contract between RLS and MNKD, you can bet the farm that Mannkind's inhalation Technosphere remains the bigger picture for RLS.
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Post by porkini on Jul 20, 2021 9:21:52 GMT -5
I only know one person with autism, but I think he would be much more likely to swallow another pill than to successfully inhale a powder. I could be wrong. Autism Spectrum - en.wikipedia.org/wiki/Autism_spectrumI have a family member with Asperger syndrome who could easily inhale. Can drive a forklift too!  |
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Post by lakon on Jul 20, 2021 22:38:19 GMT -5
While I have no idea about what RLS is actually doing with their "capsule", I thought it worth mentioning the obvious, capsules are often times filled with a dry powder, and Technosphere is not solely an inhalation technology... That's a route of application that was chosen for reasons that should be obvious by now, at least on this board, and a few reasons were mentioned in this thread, including the RLS pipeline's next steps, being inhalation to avoid digestive issues as well as faster response. If the capsule is filled with a Technosphere-based API, absorption enhancers would likely be needed; however, I find that pathway through the regulatory framework to be very interesting because inhalation is taken off the table for initial approval. Inhalation introduces a host of additional concerns and delays that could be avoided with an initial capsule. Once approved, the pathway from oral to inhalation might become somewhat more streamlined... Again, I am not saying that's what RLS is doing, but RLS and MNKD would be wise to at least consider this option. If proved successful, MNKD could offer additional partnership options to speed approvals along.
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Post by buyitonsale on Jul 22, 2021 0:07:43 GMT -5
RLS pipeline clearly shows 2 separate candidates: Cannabidiol Technosphere and Cannabidiol SNAC capsule They are for different indications as well. RLS is not moving away from MNKD Technosphere. www.receptorlife.com |
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Post by prcgorman2 on Jul 22, 2021 6:45:11 GMT -5
Besides, I think most people prefer inhaling over edibles.
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Post by mango on Jul 22, 2021 11:56:54 GMT -5
Why is this Receptor news even being discussed on the MNKD board? The PR from Receptor clearly states their proposed drug is a capsule delivery where the drug has been enhanced by using a FDA approved ORAL absorption enhancer. There is no mention, and why would they mention MNKD and the use of the Technosphere technology- MNKD’s delivery is only designed for use in inhalation dosing. Maybe I’m missing something—but IMO Receptor is telling us they have moved away from using MNKD’s services and product Incorrect. You can clearly see here on Receptor’s own website pipeline page that Cannabidiol Technosphere is one of their top priorities, listed first in their pipeline. Furthermore, their recent publication on Cannabidiol Technosphere that was disclosed in April at a major conference further underscores how heavily invested Receptor remains with MannKind’s Technosphere platform. Below the pipeline picture is a screenshot from Receptor’s PR about their publications, where Receptor’s own founder and CSO specifically mentions Technosphere and MannKind. 😃   |
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Post by peppy on Jul 22, 2021 12:17:11 GMT -5
Inhalation is different than digestion.
Inhalation to treat seizures. Acute.
Digestion... perhaps better results. The slow and constant over time.
Austism is a spectrum.
I knew a child that was labeled autistic.
I suspect a bit of asphyxia at birth.
He could talk, walk. same questions over and over.
He never learned to pedal a bicycle.
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Post by mytakeonit on Jul 22, 2021 13:28:56 GMT -5
Or, he learned that if he started his paper route at the top of the hill ... then he wouldn't have to pedal.
But, that's myformernewspaperboy'stakeonit
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Post by prcgorman2 on Jul 22, 2021 20:41:02 GMT -5
Why is this Receptor news even being discussed on the MNKD board? The PR from Receptor clearly states their proposed drug is a capsule delivery where the drug has been enhanced by using a FDA approved ORAL absorption enhancer. There is no mention, and why would they mention MNKD and the use of the Technosphere technology- MNKD’s delivery is only designed for use in inhalation dosing. Maybe I’m missing something—but IMO Receptor is telling us they have moved away from using MNKD’s services and product Thank you for making your views clear hoppingandwillting. I wasn’t sure what you intended in your earlier long rambling post (said the rambler) on UTHR and MNKD. Much appreciated. Sometimes you don’t know who or what to believe on posts you read here, but I’m sure I don’t have to tell you that. Thanks again. |
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