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Post by sugarland on Mar 12, 2019 13:39:28 GMT -5
What about positive pressure delivery? Any thoughts ?
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Post by sugarland on Mar 12, 2019 13:47:05 GMT -5
Which leads me to pulmonary embolism
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Post by peppy on Mar 12, 2019 13:48:16 GMT -5
What about positive pressure delivery? Any thoughts ? positive pressure, could be done. you could throw the stuff down an Endo tracheal tube and ventilate. Why though? An IV works just as well, or better. Clinicians can start IV's in moments.
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painter
Newbie
Adcirca = Tadalifil = Cialis = Very large market. Please correct me if inaccurate.
Posts: 3
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Post by painter on Mar 12, 2019 13:55:12 GMT -5
From third class long term investor Post prostatic surgery, 5m of Cialis or Viagra per day is recommended for extended use. 20M can be taken lasting for 3 or 4 days. Alternatively, a syringe can be carried for occasional use. Medicare does not pay for any post surgical use including ED or peyronies disease. Medicare does pay for BPH which is usually 5m per day.
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Post by peppy on Mar 12, 2019 13:58:06 GMT -5
From third class long term investor Post prostatic surgery, 5m of Cialis or Viagra per day is recommended for extended use. 20M can be taken lasting for 3 or 4 days. Alternatively, a syringe can be carried for occasional use. Medicare does not pay for any post surgical use including ED or peyronies disease. Medicare does pay for BPH which is usually 5m per day. viagra is generic now, 2 dollars for 20 mg. need 60 mg, take 3.
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Post by mango on Mar 12, 2019 23:19:26 GMT -5
During the United Therapeutics Corporation presentation at the Cowen and Company 39th Annual Health Care Conference, Martine Rothblatt says around the 17:40 mark that they also plan to develop Technosphere Treprostinil for people with PH-LD and PH-COPD. Tyvaso for PH associated with ILD and COPD are both being evaluated in Phase 3 clinical trials. PH associated with ILD currently has no approved therapies for WHO Group 3. PH associated with COPD also has no approved therapies for WHO Group 3. Systemic drugs and infusions are contraindicated here. Tens-of-thousands of patients. Technosphere Treprostinil has IP protection ranging from the mid 2020’s to the mid 2030’s. Samumed’s SMO4646 is a small molecule Wnt inhibitor for IPF. It is designed specifically for inhalation. United has INHALED DPI PDE5 FOR PAH listed as #17 in their pipeline. MannKind has Various Indications listed for their Undisclosed Technosphere Formulation that is partnered with United. “Tadalafil (Cialis®) is a drug used for treating erectile dysfunction (ED), pulmonary hypertension and benign prostatic hyperplasia (BPH). Tadalafil is in a class of drugs called phosphodiesterase-5 (PDE5) inhibitors which includes, among others, sildenafil (Viagra®) and vardenafil (Levitra®). All three drugs of these oral tablets are FDA approved and clinically indicated for the treatment of ED. Tadalafil and sildenafil are also indicated for pulmonary hypertension, but among PDE5 drugs, only tadalafil is approved for the treatment of BPH.” I believe that MannKind has all three of those within their patents. Potential ED Competitor: Adamis Pharmaceuticals Submits New Drug Application to FDA for Its Tadalafil Sublingual Tablet ir.adamispharmaceuticals.com/news-releases/news-release-details/adamis-pharmaceuticals-submits-new-drug-application-fda-itsPotential Additional Indication: Study on sildenafil combined with inhalational nitric oxide therapy on the curative effects and serum levels of HIF-1α, ET-1, and calcium in neonatal pulmonary hypertensionwww.europeanreview.org/wp/wp-content/uploads/4683-4690.pdfRelevant United Therapeutics Patent Example from Nov. 2018: 35. A method for treating pulmonary hypertension in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a phosphodiesterase type-5 inhibitor and a NO-releasing compound, wherein the therapeutically effective amount of t he phosphodiesterase type-5 inhibitor improves the half-life of the NO-releasing compound. 39. The method according to claim 37, wherein the phosphodiesterase type-5 inhibitor and the NO-releasing compound are co-administered. 40. The method according to claim 37, wherein one or both of the phosphodiesterase type-5 inhibitor and the NO-releasing compound are formulated as a pharmaceutical composition adapted for nebulization into liquid or dry powder medical aerosols for delivery by inhalation to the subject. 41. The method according to claim 40, wherein the pharmaceutical composition is administered to the subject with a metered dose inhaler such as a dry powder inhaler or a soft mist inhaler capable of delivering a fixed amount of the pharmaceutical composition per pulse. 43. The method according to claim 37, wherein the phosphodiesterase type-5 inhibitor is vardenafil or a pharmaceutically acceptable salt or prodrug thereof. patents.justia.com/patent/20180325908#claims
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Post by celo on Mar 12, 2019 23:31:09 GMT -5
Thanks mango. No wonder United is excited to partner with Mannkind.
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Post by deaner3 on Mar 13, 2019 1:33:10 GMT -5
During the United Therapeutics Corporation presentation at the Cowen and Company 39th Annual Health Care Conference, Martine Rothblatt says around the 17:40 mark that they also plan to develop Technosphere Treprostinil for people with PH-LD and PH-COPD. Tyvaso for PH associated with ILD and COPD are both being evaluated in Phase 3 clinical trials. PH associated with ILD currently has no approved therapies for WHO Group 3. PH associated with COPD also has no approved therapies for WHO Group 3. Systemic drugs and infusions are contraindicated here. Tens-of-thousands of patients. Technosphere Treprostinil has IP protection ranging from the mid 2020’s to the mid 2030’s. Samumed’s SMO4646 is a small molecule Wnt inhibitor for IPF. It is designed specifically for inhalation. United has INHALED DPI PDE5 FOR PAH listed as #17 in their pipeline. MannKind has Various Indications listed for their Undisclosed Technosphere Formulation that is partnered with United. “Tadalafil (Cialis®) is a drug used for treating erectile dysfunction (ED), pulmonary hypertension and benign prostatic hyperplasia (BPH). Tadalafil is in a class of drugs called phosphodiesterase-5 (PDE5) inhibitors which includes, among others, sildenafil (Viagra®) and vardenafil (Levitra®). All three drugs of these oral tablets are FDA approved and clinically indicated for the treatment of ED. Tadalafil and sildenafil are also indicated for pulmonary hypertension, but among PDE5 drugs, only tadalafil is approved for the treatment of BPH.” I believe that MannKind has all three of those within their patents. Potential ED Competitor: Adamis Pharmaceuticals Submits New Drug Application to FDA for Its Tadalafil Sublingual Tablet ir.adamispharmaceuticals.com/news-releases/news-release-details/adamis-pharmaceuticals-submits-new-drug-application-fda-itsPotential Additional Indication: Study on sildenafil combined with inhalational nitric oxide therapy on the curative effects and serum levels of HIF-1α, ET-1, and calcium in neonatal pulmonary hypertensionwww.europeanreview.org/wp/wp-content/uploads/4683-4690.pdfRelevant United Therapeutics Patent Example from Nov. 2018: 35. A method for treating pulmonary hypertension in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a phosphodiesterase type-5 inhibitor and a NO-releasing compound, wherein the therapeutically effective amount of t he phosphodiesterase type-5 inhibitor improves the half-life of the NO-releasing compound. 39. The method according to claim 37, wherein the phosphodiesterase type-5 inhibitor and the NO-releasing compound are co-administered. 40. The method according to claim 37, wherein one or both of the phosphodiesterase type-5 inhibitor and the NO-releasing compound are formulated as a pharmaceutical composition adapted for nebulization into liquid or dry powder medical aerosols for delivery by inhalation to the subject. 41. The method according to claim 40, wherein the pharmaceutical composition is administered to the subject with a metered dose inhaler such as a dry powder inhaler or a soft mist inhaler capable of delivering a fixed amount of the pharmaceutical composition per pulse. 43. The method according to claim 37, wherein the phosphodiesterase type-5 inhibitor is vardenafil or a pharmaceutically acceptable salt or prodrug thereof. patents.justia.com/patent/20180325908#claimsSo... are you saying that the mystery drug from United is a Cialis/Viagra inhaled replacement? Am I reading this correct? That's huge.... "that's what she said"
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Post by hellodolly on Mar 13, 2019 6:19:06 GMT -5
With all the excitement around the Technosphere platform, combined with what drugs could be potentially inhaled, I saw a commercial last night for DUPIXENT. Atopic dermatitis (Eczema) looks so painful and annoying to have to treat and live with. Their "once a day injection" seems to have a certain degree of success. I'm curious though if a lower inhaled dose is just as effective and/or provides equally or better results? Again, just like any of the other drugs being mentioned as having potential,are already FDA approved. I'm not sure what trials need to take place based on prior FDA approval but, it must be shorter in duration?
My comment is not to construe this as an indication that MNKD is seeking but, all the what if's....soon enough WS will see it too and we'll see the true value of this platform. God help you if you aren't holding.
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Post by itellthefuture777 on Mar 13, 2019 8:07:28 GMT -5
They should call it Bonaire
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Post by matt on Mar 13, 2019 8:13:54 GMT -5
See that’s the beauty of TS it’s quick in and quick out. Will doctors prescribe it off label ? That beauty is not attributable to TS delivery. TS gets a drug into the lungs rapidly and frequently that translates to a quick absorption into the circulatory system, but TS does nothing to guarantee a quick exit. How fast a drug is metabolized and excreted depends on the molecule or protein and the condition of the patient's kidneys and/or liver as virtually all drugs are broken down and excreted in the stool or urine. Insulin is quick in and out as it is intended to be a rapid-acting hormone, but other drugs may be quickly absorbed but slowly metabolized. TS delivers quickly, what happens after that requires a full ADME section in the drug application.
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Deleted
Deleted Member
Posts: 0
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Post by Deleted on Mar 13, 2019 8:22:57 GMT -5
And unfortunately EMS response time and distance traveled has huge variability I am not sure I would be able to follow directions and inhale through a dreamboat during a stroke. My brain wouldn't understand the instructions. A blank stare, if there was any response. Wouldn't be easy but having the product on an EMS unit to use on patient is possible. You have that critical and very limited time window with a stroke patient where they can be helped significantly.
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Post by Thundersnow on Mar 13, 2019 8:35:16 GMT -5
My question is since ADCIRCA is designated for PAH and there are other indications (ED & BPH) will MNKD have to talk to ELI LILY or can they go to straight to FDA and get approval since Tadalafil is in generic form?
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Post by uvula on Mar 13, 2019 8:56:34 GMT -5
My question is since ADCIRCA is designated for PAH and there are other indications (ED & BPH) will MNKD have to talk to ELI LILY or can they go to straight to FDA and get approval since Tadalafil is in generic form? Maybe Eli Lily can beg MNKD to partner with them for an inhalable cialis.
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Post by mnkdfann on Mar 13, 2019 18:51:49 GMT -5
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