|
|
Post by mango on Jun 29, 2022 12:43:48 GMT -5
Receptor Life Sciences Announces First Patient Dosed with RLS103 (Inhaled Dry Powder CBD) in Phase 1b/2a Clinical Study in Acute Anxiety within Social Anxiety Disorder SEATTLE - Receptor Life Sciences (RLS), a clinical-stage pharmaceutical company developing innovative therapies to address central nervous system disorders, announced that the first patient has been dosed in its Phase 1b/2a clinical safety, tolerability, and efficacy study evaluating RLS103 in adult patients with acute anxiety within social anxiety disorder (SAD). RLS103, a dry powder inhaled cannabidiol (CBD), uses an inhalation formulation technology coupled with a breath-powered device, both currently used in two FDA-approved products. The RLS103 inhalation powder provides IV-like pharmacokinetics and contains synthetic CBD and FDKP, an FDA-approved inhalation excipient. "Advancing the clinical development of RLS103 and dosing the first patient marks a key milestone for our company," said Mark Theeuwes, President and CEO of Receptor Life Sciences. "With no acute therapies currently available, RLS103 has the potential to offer immediate relief, in three minutes or less, for patients living with social anxiety. We expect to report topline results by early 2023." The Phase 1b/2a clinical trial is a multi-center, randomized, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, and efficacy of two doses of RLS103 in adult subjects with acute anxiety within SAD. The primary endpoint of the study is safety and tolerability. The secondary endpoints are efficacy and changes in physiologic measures of anxiety following a simulated public speaking challenge conducted in a clinical setting. The results from the Phase 1b/2a study will be used to facilitate the design of a larger, well-controlled, randomized safety and efficacy study intended for registration. According to the Anxiety and Depression Association of America and 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. www.receptorlife.com/————————————————————————————— Nice to see Receptor advancing on this product. Looks like our wild card play keeps getting better, eh? |
|
|
|
Post by peppy on Jun 29, 2022 12:59:30 GMT -5
"Receptor Life Sciences (RLS), a clinical-stage pharmaceutical company developing innovative therapies to address central nervous system disorders,"RLS has refined its focus. I wonder. Epilepsy. The insert shows our patient on FDA approved epileptic medication. On couch controlled by CBD. I am no genius however, how stupid do we have to be? Charlotte died a couple of years ago.  |
|
|
|
Post by stevil on Jun 29, 2022 14:19:18 GMT -5
Just a hunch... if the changes in body habitus were caused by medications, it's likely due to high dose steroids. Antiepileptics don't normally cause changes like that. In fact, most of them decrease appetite and lead to weight loss. Topamax is often used for this purpose.
|
|
|
|
Post by mango on Jun 29, 2022 14:19:43 GMT -5
Excellent results from this trial may spark a big pharmaceutical partnership for RLS.
Exciting times.
|
|
|
|
Post by peppy on Jun 29, 2022 14:32:42 GMT -5
Just a hunch... if the changes in body habitus were caused by medications, it's likely due to high dose steroids. Antiepileptics don't normally cause changes like that. In fact, most of them decrease appetite and lead to weight loss. Topamax is often used for this purpose. off topic, quote, "likely due to high dose steroids." Yes, I had heard about this. Was it referred to as moon face? I feel bad to the kids, they don't feel well. |
|
|
|
Post by mango on Jun 29, 2022 14:48:54 GMT -5
|
|
|
|
Post by mango on Jun 29, 2022 15:21:15 GMT -5
Guys, we could have an FDA approved Technosphere Cannabidiol product by 2025-2026. Very exciting. I’m just throwing those dates out as a best guess. Assume they start Phase 3 late 2023 early 2024 and it takes 12-18 months for completion and then 6 months for FDA response.
|
|
|
|
Post by neil36 on Jun 29, 2022 16:16:53 GMT -5
Here is an excerpt from 2016 news. It mentioned addressing possible conditions such as chronic pain, neurological diseases and inflammatory disorders. Right now, on the RLS pipeline page, the only condition DPI will address is acute anxiety with social anxiety disorder. I thought at one point their pipeline said DPI was going to address PTSD, but I'm not sure if I remember that correctly.
"MannKind Corp.MNKD announced that it has signed a collaboration and license agreement with Receptor Life Sciences, Inc. to develop multiple inhaled therapeutic products for conditions that like chronic pain, neurologic diseases, and inflammatory disorders.
As per terms of the agreement, MannKind will work with Receptor to develop inhaled formulations of certain undisclosed compounds and will perform initial formulation studies. On the other hand, Receptor will be responsible for manufacturing and commercialization. The companies will collaborate on the development of the products, with development costs being financed by Receptor.
MannKind is eligible to receive up to $102.25 million as development and commercialization milestones, along with mid-single to low double-digit royalties, on net product sales."
|
|
|
|
Post by sayhey24 on Jun 29, 2022 18:24:16 GMT -5
Mango - RLS103 IMO is a HUGE" deal and a potential blockbuster. I wonder where the manufacturing will be done.
|
|
|
|
Post by uvula on Jun 30, 2022 7:44:27 GMT -5
They are using synthetic CBD. I thought the huge hurdle for years was the federal Marijuana law. But hasn't synthetic cbd be legal forever? What am I missing?
(I think I asked this same question a year ago.)
|
|
|
|
Post by slapshot on Jun 30, 2022 8:18:54 GMT -5
They are using synthetic CBD. I thought the huge hurdle for years was the federal Marijuana law. But hasn't synthetic cbd be legal forever? What am I missing? (I think I asked this same question a year ago.) perhaps this is relevant?
In 2018, President Donald J. Trump signed the Agriculture Improvement Act of 2018 into law. Under this law, CBD products containing less than 0.3 percent tetrahydrocannabinol, the compound that produces a “high,” are no longer classified as controlled substances that are categorically illegal under federal law. Instead, the 2018 legislation authorizes FDA to regulate sale of CBD products pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA).
|
|
|
|
Post by uvula on Jun 30, 2022 8:36:48 GMT -5
They are using synthetic CBD. I thought the huge hurdle for years was the federal Marijuana law. But hasn't synthetic cbd be legal forever? What am I missing? (I think I asked this same question a year ago.) Thank you slapshot. My assumption was wrong. All types of cbd were restricted until recently. |
|
|
|
Post by cretin11 on Jun 30, 2022 9:05:59 GMT -5
CBD is widely available, you can find it in drug stores, supermarkets, gas stations, etc. Not much oversight to production, hence plenty of subpar product on the market. But also many legitimate, ethical and high grade CBD producers all over the country.
Most experts will tell you the “full spectrum” CBD products have much better efficacy than the synthetic or isolate products. That’s because of the so called “entourage effect” of full spectrum CBD, with the dozens of terpenes and chemical compounds that create the beneficial effects. Some people need to use the synthetic or isolate because they take drug tests. Full spectrum CBD has a risk of positive drug test because a minuscule amount of THC can show up.
While many users tend to eat CBD gummies, it’s also widely used in capsule form. Those are relatively slow acting. The fastest may be smoking it of course, but most folks don’t want that. A good in between method is by tincture. Also widely used and they act within minutes.
For a TS version to be commercially viable, IMO a key will be getting it priced competitively. Right now the top grade CBD tinctures are easily found for under a dollar per dosage. Also I don’t know if RLS is developing a full spectrum product or if they are limited to isolate/synthetic, would be curious to know that.
|
|
|
|
Post by mango on Jun 30, 2022 14:20:24 GMT -5
CBD is widely available, you can find it in drug stores, supermarkets, gas stations, etc. Not much oversight to production, hence plenty of subpar product on the market. But also many legitimate, ethical and high grade CBD producers all over the country. Most experts will tell you the “full spectrum” CBD products have much better efficacy than the synthetic or isolate products. That’s because of the so called “entourage effect” of full spectrum CBD, with the dozens of terpenes and chemical compounds that create the beneficial effects. Some people need to use the synthetic or isolate because they take drug tests. Full spectrum CBD has a risk of positive drug test because a minuscule amount of THC can show up. While many users tend to eat CBD gummies, it’s also widely used in capsule form. Those are relatively slow acting. The fastest may be smoking it of course, but most folks don’t want that. A good in between method is by tincture. Also widely used and they act within minutes. For a TS version to be commercially viable, IMO a key will be getting it priced competitively. Right now the top grade CBD tinctures are easily found for under a dollar per dosage. Also I don’t know if RLS is developing a full spectrum product or if they are limited to isolate/synthetic, would be curious to know that. FDA and the medical community like single molecule drugs. They are typically easier to work with and control and understand. The issue with CBD products in commerce right now is they aren’t regulated. You’re going to be getting impurities in these unregulated products, inconsistent ingredient quantities and qualities, etc…whereas with single molecule CBD, you’re getting a regulated product with a precise dosage every single time. You’re getting no impurities and a high purity of CBD compared to whole plant extract. Most of the whole plant CBD products in commerce today will contain multiple impurities that exceed the guideline of the NIH. In order to get the quality needed by regulatory bodies, the only way to do that is synthetically. GW’s plant based products are a one off and not something the market will see repeated by many now that commercial supplies of CBD are available. It’s also extremely cost inefficient and not realistic for long term and grand scale. Requires tremendous real estate as well. Synthetic CBD can be made in an already FDA approved API facility (MannKind has one of those already). Then there is insurance coverage and clinical trials. What’s in commerce isn’t regulated and hasn’t undergone rigorous clinical testing under FDA scrutiny. Bottom line, what Receptor is attempting is, unfortunately, the prevailing way that regulatory bodies and framework correlate best with. I will personally always lean towards whole plant Cannabis and whole plant based medicine, but when it comes to medical illnesses, FDA and other foreign regulatory entities have the framework designed to favor synthetics, and it’s what you’re going to see going forward as far as pharma grade FDA cannabinoid products goes. |
|
|
|
Post by markado on Jul 1, 2022 18:43:49 GMT -5
Guys, we could have an FDA approved Technosphere Cannabidiol product by 2025-2026. Very exciting. I’m just throwing those dates out as a best guess. Assume they start Phase 3 late 2023 early 2024 and it takes 12-18 months for completion and then 6 months for FDA response. The 505 B2 pathway may accelerate time to market. This could be used for Social Anxiety Disorder, acute anxiety, Possibly PTSD, and in less than Rx quants/strengths, recreationally for calming effects, and as an inhalable replacement for epidiolex...maybe. All good stuff in high value markets. |
|
