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Post by mnholdem on Apr 23, 2017 15:55:37 GMT -5
I was a bit surprised to stumble across an abstract summarizing that inhaled trepostinil has already had clinical trials which have demonstrated its efficacy in treating PAH when combined with oral PAH medications. Excerpt:
This trial demonstrates that, among PAH patients who remain symptomatic on bosentan or sildenafil, inhaled treprostinil improves exercise capacity and quality of life and is safe and well-tolerated. (TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension; NCT00147199).Source: www.ncbi.nlm.nih.gov/pubmed/20430262This was a Phase 3 trial in which the experimental trepostinil was administered using an ultrasonic nebulizer. clinicaltrials.gov/show/NCT00147199  |
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Post by ssiegel on Apr 23, 2017 20:20:40 GMT -5
I was a bit surprised to stumble across an abstract summarizing that inhaled trepostinil has already had clinical trials which have demonstrated its efficacy in treating PAH when combined with oral PAH medications. Excerpt:
This trial demonstrates that, among PAH patients who remain symptomatic on bosentan or sildenafil, inhaled treprostinil improves exercise capacity and quality of life and is safe and well-tolerated. (TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension; NCT00147199).Source: www.ncbi.nlm.nih.gov/pubmed/20430262This was a Phase 3 trial in which the experimental trepostinil was administered using an ultrasonic nebulizer. clinicaltrials.gov/show/NCT00147199 It's already on the market: www.tyvaso.com/dtc/taking-tyvaso |
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Post by lakers on Apr 23, 2017 21:08:16 GMT -5
As for Treprostinil, we are making progress with this pipeline product and I believe we may have already scheduled a pre-IND meeting with the FDA at the end of June. Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=19#ixzz4f82b92sCTHale's competitor is UTHR Tyvaso which targets 2 indications using the huge, cumbersome bong shown below. Because of Tyvaso mkt acceptance, THale may have an easier time than Afrezza. www.tyvaso.com/Content/dtc/pdf/TD100_Instructions_for_Use.pdfPhase III trial of Tyvaso for a version of interstitial lung disease which manifest pulmonary hypertension. This is a completely different disease from the pulmonary hypertension treated by ourselves and all of our competitors today. In fact, there is no drugs (11:28) all approved for what's called WHO Group 3 pulmonary hypertension associated with interstitial lung disease. Interstitial lung disease ranges from things like – well, probably one of the most famous is idiopathic pulmonary fibrosis. statistics show that there are 30,000 patients who are dying regularly, mean survival of just a handful of years from Group 3 PAH with no approved medicines. It would be a completely virgin so-called blue water type of opportunity for Tyvaso to move into. And capturing as few as a fourth or a third of those patients would result in revenues at the $1 billion level, not to mention the continued growth of that drug in Group 1 pulmonary hypertension. We’re involved in conversations with the FDA regarding the regulatory pathway for an anaphylaxis indication. We are also assessing the possible indications for possible other indications for epi as well. [That could be for mild asthma at low dosage.] For Treprostinil, we submitted a pre-IND meeting request with the FDA on March 8, and we expect to have the meetings with the FDA sometime in May to further articulate what the Treprostinil program may look like. Read more: mnkd.proboards.com/user/1882/recent?page=3#ixzz4f820oCXmWe are going progress the pipeline. We’ve had to start some of these programs quite a lot because we just enough to cash to do it. We need to be successful before we go too far. But our Epi program has gotten a lot of press given the controversy around epinephrine but we do have an inhaled Epi program that’s not in the clinic yet, but we’ve shown feasibility and formulation and so forth and it’s ready to move there. We did meet with the FDA and map out a clinical strategy, so I think that’s ready to go. We also have programs in Treprostinil and Palonosetron and I could spend a lot of time talking about those. We think they are attracting targets because of the way the regulatory pathway works for those. These are essentially generics at this point. We can reformulate them into an inhaled formulation and give them some vantages. So for example for Treprostinil, this is typically done with a nebulizer today. It’s a very long involved treatment and the treatment doesn’t last terribly long. So introducing something you could do with obviously just a few seconds with Afrezza, we think we have some interesting advantages. At the same time Palonosetron typically only given in the doctor’s office. This is injection today. If we could give a home version by inhalation it has some nice advantages in the chemo-induced nausea and vomiting setting. And we continue to just look at other areas as well. And recently we showed this data. This is from an orally inhaled hormone [PTH], interesting way to get into your system and does exactly as we typically see, which is its rapid peak, since we call a pulsatile delivery which is important in these kind of settings, and then it goes away relatively quickly. So this is exactly what you want to see for a drug like this. www.seekingalpha.com/article/4054768Read more: mnkd.proboards.com/user/1882/recent?page=3#ixzz4f83ltuQj |
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Post by peppy on Apr 24, 2017 7:18:51 GMT -5
I was a bit surprised to stumble across an abstract summarizing that inhaled trepostinil has already had clinical trials which have demonstrated its efficacy in treating PAH when combined with oral PAH medications. Excerpt:
This trial demonstrates that, among PAH patients who remain symptomatic on bosentan or sildenafil, inhaled treprostinil improves exercise capacity and quality of life and is safe and well-tolerated. (TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension; NCT00147199).Source: www.ncbi.nlm.nih.gov/pubmed/20430262This was a Phase 3 trial in which the experimental trepostinil was administered using an ultrasonic nebulizer. clinicaltrials.gov/show/NCT00147199 It's already on the market: www.tyvaso.com/dtc/taking-tyvasoINDICATION
Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH) (WHO Group 1), which is high blood pressure in the arteries of your lungs. Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor antagonist, (ERA)) or sildenafil (a phosphodiesterase-5 (PDE-5) inhibitor). Your ability to do exercise decreases 4 hours after taking Tyvaso.
www.tyvaso.com/dtc/taking-tyvaso www.tyvaso.com/pdf/Tyvaso-PI.pdf
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Post by #NoMoreNeedles on Aug 17, 2017 3:58:55 GMT -5
Are you suggesting MannKind may be working with United Therapeutics on PAH?
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Post by matt on Aug 17, 2017 7:33:36 GMT -5
Are you suggesting MannKind may be working with United Therapeutics on PAH? They wouldn't need to work with United Therapeutics because a federal court ruled that the patent on Trepostinil was invalid. It is now the equivalent of a generic drug, and there are others who have commercialized their own version of the drug to compete with Tyvaso. Inhalation is not the only way to get the drug into the patient; the drug can be administered by injection, intravenously, or orally with extended release tablets. |
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Post by lakon on Aug 17, 2017 9:50:17 GMT -5
Are you suggesting MannKind may be working with United Therapeutics on PAH? They wouldn't need to work with United Therapeutics because a federal court ruled that the patent on Trepostinil was invalid. It is now the equivalent of a generic drug, and there are others who have commercialized their own version of the drug to compete with Tyvaso. Inhalation is not the only way to get the drug into the patient; the drug can be administered by injection, intravenously, or orally with extended release tablets. Please, provide a source. I was only aware of the following that has to do with a new improved method of production. I still agree with you because the patent was to expire soon, and this new one was the method to extend the patent from what I recall. For this reason, I thought UTHR would partner with MNKD to snatch up a real improvement that will be patented: "Tyvasosphere" sounds good to me, not to mention the other long-term benefits of collaboration between the two. www.law360.com/articles/908694/ptab-invalidates-patent-for-hypertension-treatment |
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Post by dreamboatcruise on Aug 17, 2017 10:37:12 GMT -5
Are you suggesting MannKind may be working with United Therapeutics on PAH? They wouldn't need to work with United Therapeutics because a federal court ruled that the patent on Trepostinil was invalid. It is now the equivalent of a generic drug, and there are others who have commercialized their own version of the drug to compete with Tyvaso. Inhalation is not the only way to get the drug into the patient; the drug can be administered by injection, intravenously, or orally with extended release tablets. I'm curious... if this is available as extended release tablet why are some using a nebulizer and subq infusion pumps? I only recall MNKD management discussing it compared to the existing inhaled option. Is there a clinical benefit to direct delivery to lungs such as addressing sudden acute worsening of symptoms? |
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Post by thall on Aug 17, 2017 16:30:18 GMT -5
They wouldn't need to work with United Therapeutics because a federal court ruled that the patent on Trepostinil was invalid. It is now the equivalent of a generic drug, and there are others who have commercialized their own version of the drug to compete with Tyvaso. Inhalation is not the only way to get the drug into the patient; the drug can be administered by injection, intravenously, or orally with extended release tablets. I'm curious... if this is available as extended release tablet why are some using a nebulizer and subq infusion pumps? I only recall MNKD management discussing it compared to the existing inhaled option. Is there a clinical benefit to direct delivery to lungs such as addressing sudden acute worsening of symptoms? There are actually three oral drugs used to treat PAH: Opsumit, Adempas, and Orenitram. PAH appears to be tricky to treat and may require different combinations to get a therapeutic effect.
This compares routes for trepostinil: link.springer.com/article/10.1007/s40262-016-0409-0
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Post by dreamboatcruise on Aug 17, 2017 16:39:48 GMT -5
I'm curious... if this is available as extended release tablet why are some using a nebulizer and subq infusion pumps? I only recall MNKD management discussing it compared to the existing inhaled option. Is there a clinical benefit to direct delivery to lungs such as addressing sudden acute worsening of symptoms? There are actually three oral drugs used to treat PAH: Opsumit, Adempas, and Orenitram. PAH appears to be tricky to treat and may require different combinations to get a therapeutic effect. Isn't there also a Trespostinil pill used for PAH? If it is in pill form and can do extended release, it appears that patients need to take it throughout the day, so why is an inhaled form needed rather than just the pill. I'm sure I'm missing something here and looking for an answer... not trying to claim their isn't a need for inhalable. I know relatively little about PAH (other than the basic what it is) vs diabetes. |
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Post by thall on Aug 17, 2017 16:49:13 GMT -5
There are actually three oral drugs used to treat PAH: Opsumit, Adempas, and Orenitram. PAH appears to be tricky to treat and may require different combinations to get a therapeutic effect. Isn't there also a Trespostinil pill used for PAH? If it is in pill form and can do extended release, it appears that patients need to take it throughout the day, so why is an inhaled form needed rather than just the pill. I'm sure I'm missing something here and looking for an answer... not trying to claim their isn't a need for inhalable. I know relatively little about PAH (other than the basic what it is) vs diabetes. Yes, orenitram is the extended release pill form that is taken 2-3 times a day. Based upon what I read, it boils down to achieving a therapeutic effect while trying to minimize side effects -- whatever combination works best. This link gives more details: link.springer.com/article/10.1007/s40262-016-0409-0 |
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Post by peppy on Aug 17, 2017 17:10:43 GMT -5
Isn't there also a Trespostinil pill used for PAH? If it is in pill form and can do extended release, it appears that patients need to take it throughout the day, so why is an inhaled form needed rather than just the pill. I'm sure I'm missing something here and looking for an answer... not trying to claim their isn't a need for inhalable. I know relatively little about PAH (other than the basic what it is) vs diabetes. Yes, orenitram is the extended release pill form that is taken 2-3 times a day. Based upon what I read, it boils down to achieving a therapeutic effect while trying to minimize side effects -- whatever combination works best. This link gives more details: link.springer.com/article/10.1007/s40262-016-0409-0 www.orenitram.com/pdf/orenitram_full_prescribing_information.pdf
Headache 63%
Diarrhea 30%
Nausea 30%
Flushing 15%
Pain in jaw 11%
Pain in extremity 14%
Hypokalemia 9%
Abdominal discomfort 6%
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Post by brotherm1 on Aug 13, 2019 0:27:06 GMT -5
They wouldn't need to work with United Therapeutics because a federal court ruled that the patent on Trepostinil was invalid. It is now the equivalent of a generic drug, and there are others who have commercialized their own version of the drug to compete with Tyvaso. Inhalation is not the only way to get the drug into the patient; the drug can be administered by injection, intravenously, or orally with extended release tablets. Please, provide a source. I was only aware of the following that has to do with a new improved method of production. I still agree with you because the patent was to expire soon, and this new one was the method to extend the patent from what I recall. For this reason, I thought UTHR would partner with MNKD to snatch up a real improvement that will be patented: "Tyvasosphere" sounds good to me, not to mention the other long-term benefits of collaboration between the two. www.law360.com/articles/908694/ptab-invalidates-patent-for-hypertension-treatmentWhen lakon talks, people listen |
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paul
Researcher
Posts: 134
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Post by paul on Aug 13, 2019 2:04:14 GMT -5
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Post by lennymnkd on Aug 15, 2019 19:37:27 GMT -5
Possibilities are endless! ( cure found for deadliest strain of Tuberculosis) HORRIFIC DISEASE.. in today’s NYT’s ..DRUGS. How they are administered are a problem in themselves. Technosphere seems tailored made for the treatment..of tuberculosis
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