|
|
Post by patience1 on Oct 7, 2024 12:54:33 GMT -5
MNKD might want to look into carrying levodopa on technosphere to treat Parkinson's.
|
|
|
|
Post by cjm18 on Oct 7, 2024 14:24:12 GMT -5
MNKD might want to look into carrying levodopa on technosphere to treat Parkinson's. ChatGPT “ Inbrija is an inhalable form of levodopa, developed by Acorda Therapeutics, designed to treat off episodes in patients with Parkinson’s disease who are already taking oral levodopa/carbidopa. “Off episodes” are periods when a patient’s regular oral medication is not controlling their symptoms effectively, leading to a temporary return of motor symptoms such as tremors, stiffness, and difficulty moving. Key Features of Inbrija: 1. Inhalable Delivery: Inbrija delivers levodopa through inhalation, allowing the drug to be absorbed quickly through the lungs into the bloodstream. This provides a faster onset of action compared to oral levodopa, which must be absorbed through the digestive system. 2. Formulation: The medication comes as a powder, which is inhaled using a specialized breath-activated device called the Inbrija inhaler. The device is designed to be easy to use and portable, so patients can administer the drug quickly when they feel an “off” episode starting. 3. On-Demand Symptom Relief: Inbrija is intended to provide rapid relief from Parkinson’s symptoms during off episodes, with effects noticeable within 10–30 minutes after inhalation. It is not a replacement for daily oral levodopa/carbidopa but rather a supplemental therapy to manage sudden off periods. 4. Dosing: Patients typically use Inbrija as needed, up to 5 times per day. The dose is administered through two inhalations per dose. Benefits of Inbrija: • Faster Onset: Oral levodopa takes longer to start working (30–60 minutes) due to the need for digestion and absorption, especially if taken with food. In contrast, inhaled levodopa bypasses the digestive tract and provides more rapid relief. • Convenience: Inbrija allows patients to self-manage their off periods more effectively throughout the day, without the need for an additional oral pill. Side Effects: While Inbrija provides benefits for off episodes, it can have side effects, including: • Cough: The most common side effect, occurring because the drug is inhaled. • Upper Respiratory Issues: Such as upper respiratory infections or throat irritation. • Nausea: Like oral levodopa, though potentially less frequent. • Dyskinesia: The involuntary movements that can occur with higher doses of levodopa. Limitations: • Specific Use: Inbrija is not intended for continuous management of Parkinson’s symptoms but is instead an as-needed treatment for off episodes. • Not Suitable for Everyone: Patients with respiratory conditions like asthma or chronic obstructive pulmonary disease (COPD) may not be able to use Inbrija due to the inhalation mechanism. Clinical Impact: Inbrija has been shown to significantly improve patient management of off episodes, allowing for better control of unpredictable motor symptoms in the short term. It represents a step forward in terms of convenience and speed of symptom control, especially during periods when oral medication becomes less effective. MannKind’s Technosphere platform, with its rapid pulmonary delivery technology, could potentially be used for similar applications, given its success with drugs like Afrezza (inhaled insulin). Are you thinking of how this could translate into future innovations in Parkinson’s treatment?” |
|
|
|
Post by peppy on Oct 7, 2024 14:32:13 GMT -5
www.inbrija.com/prescribing-information.pdfINBRIJA is an aromatic amino acid indicated for the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa (1) ______________ DOSAGE FORMS AND STRENGTHS _____________ Inhalation powder: INBRIJA capsules contain 42 mg levodopa for use with the INBRIJA inhaler (3)
|
|
|
|
Post by cjm18 on Oct 7, 2024 17:02:36 GMT -5
Sales are only 40 million. Non inhaled is over 1 billion.
|
|
|
|
Post by patience1 on Oct 8, 2024 8:03:45 GMT -5
Non-inhaled sales 1 billion inhaled 40 million = market opportunity. Time in range could be just as beneficial to a Parkinson's patient as an insulin patient in terms of quality of life. More studies of time in range for Parkinson's patients would be studies worth doing.
|
|
|
|
Post by uvula on Oct 8, 2024 10:26:10 GMT -5
It makes sense for mnkd to turn an injected drug or nebulized drug into a technosphere dry powder version of the drug.
It makes less sense to try to take a dry powder inhaled drug that is already on the market and develop a technosphere version of it.
|
|
|
|
Post by ktim on Oct 8, 2024 11:10:03 GMT -5
It makes sense for mnkd to turn an injected drug or nebulized drug into a technosphere dry powder version of the drug. It makes less sense to try to take a dry powder inhaled drug that is already on the market and develop a technosphere version of it. And it's only some injected, or oral, drugs that would have any benefit converting to DPI... those where faster absorption is needed and those with tolerability issues that would improve by avoiding the digestive tract. |
|
|
|
Post by hellodolly on Oct 8, 2024 15:17:00 GMT -5
It makes sense for mnkd to turn an injected drug or nebulized drug into a technosphere dry powder version of the drug. It makes less sense to try to take a dry powder inhaled drug that is already on the market and develop a technosphere version of it. Agreed here, and to add to their options, approaching a potentially interested party who has a drug that is coming off patent. I see their technology as a platform or gateway for IP protections for BP. The cost of simply maintaining the status quo may backfire unless they can find a way to reconstitute the formulation and extend the patent. |
|
|
|
Post by ktim on Oct 8, 2024 19:32:11 GMT -5
It makes sense for mnkd to turn an injected drug or nebulized drug into a technosphere dry powder version of the drug. It makes less sense to try to take a dry powder inhaled drug that is already on the market and develop a technosphere version of it. Agreed here, and to add to their options, approaching a potentially interested party who has a drug that is coming off patent. I see their technology as a platform or gateway for IP protections for BP. The cost of simply maintaining the status quo may backfire unless they can find a way to reconstitute the formulation and extend the patent. Though unless there is compelling medical reason, insurance isn't going to continue paying branded prices if a generic of the API is available. |
|
|
|
Post by agedhippie on Oct 8, 2024 20:48:09 GMT -5
Agreed here, and to add to their options, approaching a potentially interested party who has a drug that is coming off patent. I see their technology as a platform or gateway for IP protections for BP. The cost of simply maintaining the status quo may backfire unless they can find a way to reconstitute the formulation and extend the patent. It would not protect the drug coming off patent in it's current form, only in a DPI form. If the drug was injected then a DPI version would not block a competitor from producing generic injected version. There is also the issue of getting patent protection for the DPI form unless you can show unique therapeutic properties or you are in danger of hitting the obviousness barrier. |
|
|
|
Post by hellodolly on Oct 10, 2024 7:34:14 GMT -5
Agreed here, and to add to their options, approaching a potentially interested party who has a drug that is coming off patent. I see their technology as a platform or gateway for IP protections for BP. The cost of simply maintaining the status quo may backfire unless they can find a way to reconstitute the formulation and extend the patent. It would not protect the drug coming off patent in it's current form, only in a DPI form. If the drug was injected then a DPI version would not block a competitor from producing generic injected version. There is also the issue of getting patent protection for the DPI form unless you can show unique therapeutic properties or you are in danger of hitting the obviousness barrier. Agreed, and in part this is very possible. Take a look at the current trials on Clofazimine. The current treatment for NTM has, from what we've heard from Mike, several high grade AEs that make it near intolerable and a certain population of patients give the treatment up as a result. The safety and dose studies in PHI with the nebulizer version sets itself apart in a few ways that I feel can fit your criteria and address the insurance issues noted by ktim 1. Lower doses of the Clofazimine could show a reduction in overall toxicity levels reducing current AEs seen with the pill (as measured in trial endpoints) 2. Length of treatment is cut in half vs the current SoC (6 months Nebulizer vs 1 year oral pill). 3. A reduction in AEs and treatment results in less time under direct supervision of a doctor which results in time saved and insurance costs per visit, etc. 4. Could see adoption as best treatment for patients getting positive feed back from patients and providers. All of this will have to play out but, I suspect that the MNKD team has already taken a look at these opportunities and decided they can target this indication using their technology and see the clinical and financial benefits, long before they actually put money into it, outweigh the risk. The clinical pathway hurdles are clear, the trials are underway and the pathway to success will depend on those endpoints being stat sig. Until then, we'll just have to wait. GLTA. |
|
|
|
Post by ktim on Oct 10, 2024 8:01:11 GMT -5
I am cautiously optimistic 201 trial has good tolerability data that gives share price its next leg up. And right now luck seems to be with me. Just got run over by a hurricane and didn't even lose power.
|
|
