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Post by cretin11 on Aug 19, 2021 9:54:06 GMT -5
Great find casualinvestor. It makes sense they are using an isolate for this. But I wonder if down the road it could be done with full-spectrum instead, and perhaps integrate terpenes into to formulations for certain purposes.
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Post by uvula on Aug 19, 2021 12:24:37 GMT -5
Casual, if this was done with hemp, does this mean it could have been done years ago before the pot restrictions were loosened? Is there any advantage to cbd from pot?
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Post by casualinvestor on Aug 19, 2021 15:00:02 GMT -5
I know very little about CBD, hemp, pot or terpenes. I pulled that info out of the publication peppy linked
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Post by cretin11 on Aug 19, 2021 16:36:11 GMT -5
Casual, if this was done with hemp, does this mean it could have been done years ago before the pot restrictions were loosened? Is there any advantage to cbd from pot? Yes to your first question. Second question is more nuanced. However, whether CBD is derived from hemp or marijuana, at the molecular level the CBD itself is the same. So when using an isolate (as it appears this RLS product is), then it doesn’t matter which type of plant is used. If a CBD product is “full spectrum” that means it contains some amount of other cannabinoids and terpenes in addition to CBD. For that reason they say full spectrum CBD products give users the “entourage effect” (the synergy between the various cannabinoids and terpenes). Unless a person has to worry about drug testing, it’s generally recommended to use a full spectrum CBD product rather than a CBD isolate product. That’s so you get the benefit of the entourage effect. Furthermore, a marijuana full spectrum product will have a different (basically a lot more) of an entourage effect because it’s more loaded with cannabinoids and terpenes than hemp. Sorry, long answer to your short question. |
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Post by neil36 on Mar 30, 2022 13:06:01 GMT -5
finance.yahoo.com/news/receptor-life-sciences-announces-fda-120000118.htmlSEATTLE, March 30, 2022--(BUSINESS WIRE)--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) accepted its Investigational New Drug (IND) application for RLS103. RLS103, a dry powder inhaled cannabidiol (CBD), is a first-in-class drug/device combination product for the acute treatment of social anxiety disorder. RLS103 uses a drug delivery technology comprising a proprietary CBD inhalation powder and a breath-powered device used in an FDA-approved product. RLS is initiating a proof-of-concept Phase 1b clinical safety and efficacy study in social anxiety disorder. The results will be used to facilitate the design of a larger, well-controlled, randomized Phase 2/3 safety and efficacy study intended for registration. The RLS103 inhalation powder contains synthetic CBD and FDKP, an FDA-approved inhalation excipient. In an initial proof-of-concept pharmacokinetic clinical study, RLS103 provided immediate CBD absorption with peak concentration less than 4 minutes after inhalation. Compared to oral CBD (Epidiolex® oral solution), bioavailability was 9-fold higher, and peak concentrations were 71-fold higher following RLS103 inhalation according to data published in the Journal of Pharmaceutical Sciences. Additionally, first-pass hepatic metabolites were essentially absent. This observation is directly opposite to that seen after oral CBD administration, where circulating hepatic metabolites are about 10-fold higher than circulating CBD. "No currently available therapies address the challenge of providing immediate relief for patients living with social anxiety," said Mark Theeuwes, President and CEO, Receptor Life Sciences. "This IND acceptance allows us to test RLS103 in a number of clinical proof-of-concept safety and efficacy studies. The results will guide continued development in indications that show the most promise. RLS103 has the potential to be the first-in-class treatment for acute anxiety disorders." According to the Anxiety and Depression Society of America, panic disorder affects about 5.4 million adults in the United States, according to the National Institute of Mental Health. Social Anxiety Disorder affects about 15 million adults in the U.S. and is the second-most commonly diagnosed anxiety disorder. About Receptor Life Sciences Receptor Life Sciences is a pharmaceutical company that applies FDA-approved drug delivery technologies to develop innovative therapies to address central nervous system disorders that have few safe and effective treatments. Receptor Life Sciences uses these technologies to produce inhaled and oral cannabinoid products that hold the potential to provide precision, consistency, reliability, and convenience. For more information about Receptor Life Sciences, its patented product candidates and its progress toward FDA approval, see www.receptorlife.com. View source version on businesswire.com: www.businesswire.com/news/home/20220330005056/en/Contacts David Sheon dsheon@whitecoatstrategies.com 202 422-6999
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Post by sayhey24 on Mar 30, 2022 13:51:01 GMT -5
The RLS103 inhalation powder contains synthetic CBD? That's interesting. I wonder when RLS start using synthetic CBD?
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Post by lennymnkd on Mar 30, 2022 16:17:13 GMT -5
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Post by sayhey24 on Mar 30, 2022 18:48:37 GMT -5
I really think this is great news. If RLS ever does get an approved product this could make Tyvaso DPI look like small potatoes. It could also have bigger potential than afrezza. I wonder who will manufacture the technosphere product? This could be the product Perdue said they had.
“Synthetic CBD has huge potential – it is a messy process extracting something from a plant – especially one that is very absorbent and can easily bring heavy metals along for the ride. So, synthetics unlock a lot of this – it is not shown to be toxic at any level when applied topically, for example. I think they will unleash a whole new realm of products, and people won’t have to use things like commonly used painkillers unless we need to in the future, as we will have an as-pure alternative that doesn’t have the same kind of side effects.”
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Post by sellhighdrinklow on Mar 30, 2022 20:34:43 GMT -5
Is MNKD'S maximum from RLS capped at $100 million? I e asked this before but I can't remember the answer. TYIA.
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Post by bthomas55ep on Mar 30, 2022 23:09:35 GMT -5
Is MNKD'S maximum from RLS capped at $100 million? I e asked this before but I can't remember the answer. TYIA. As I recall from the agreement,the $100 Million is associated with clinical development milestones. Once approved MNKD would be eligible to receive a low double digit ongoing royalty from sales. |
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Post by akemp3000 on Mar 31, 2022 5:02:53 GMT -5
It's starting to make sense why Al Mann's key person, Dr. Andrea Leone-Bay, kind of sort of, left Mannkind. She apparently saw the potential that's now beginning to unfold. Her credentials are far too strong to think she didn't see a powerful opportunity. IMO, this all goes back to Al Mann's wife suffering from migraines and typical Al wanting to tackle another giant unmet need.
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Post by sayhey24 on Mar 31, 2022 6:11:40 GMT -5
Is MNKD'S maximum from RLS capped at $100 million? I e asked this before but I can't remember the answer. TYIA. As I recall from the agreement,the $100 Million is associated with clinical development milestones. Once approved MNKD would be eligible to receive a low double digit ongoing royalty from sales. If they do the same kind of deal as they did with UTHR, they would also have cost plus manufacturing. |
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Post by mango on Mar 31, 2022 7:25:00 GMT -5
Absolutely fantastic news! So great to see Receptor making real progress with Technosphere Cannabidiol.
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Post by peppy on Mar 31, 2022 7:33:08 GMT -5
I really think this is great news. If RLS ever does get an approved product this could make Tyvaso DPI look like small potatoes. It could also have bigger potential than afrezza. I wonder who will manufacture the technosphere product? This could be the product Perdue said they had. “Synthetic CBD has huge potential – it is a messy process extracting something from a plant – especially one that is very absorbent and can easily bring heavy metals along for the ride. So, synthetics unlock a lot of this – it is not shown to be toxic at any level when applied topically, for example. I think they will unleash a whole new realm of products, and people won’t have to use things like commonly used painkillers unless we need to in the future, as we will have an as-pure alternative that doesn’t have the same kind of side effects.” applied topically, for example. "I think they will unleash a whole new realm of products, and people won’t have to use things like commonly used painkillers " Holy mackerel there is a thought. Bring on the trials. |
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Post by markado on Mar 31, 2022 7:52:16 GMT -5
This is great news, and I agree, on a global scale, this could easily be bigger than Afrezza, as both mature. The key here is controlled and consistent dose amounts and levels of concentration. Extracting CBD from plants leads to harmonization/homogenization of concentrations - a messy and imperfect process. What RLS is doing is learning from nature, but applying science to effect a more predictable outcome, every time.
Also, does anyone recall a possibility for a MNKD equity stake in RLS through a convertible loan or something? I agree with the milestones, royalties and likelihood of a manufacturing agreement.
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