Claims for Patent: 8,846,112

Summary for Patent: 8,846,112

Title:	Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation
Abstract:	Disclosed are methods of distributing a pharmaceutical product comprising nitric oxide gas. The methods include supplying a source of nitric oxide gas to a medical provider, informing the medical provider about a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure, and providing a warning about use of inhaled nitric oxide in patients with pre-existing left ventricular dysfunction.
Inventor(s):	Baldassarre; James S. (Doylestown, PA)
Assignee:	INO Therapeutics LLC (Hampton, NJ)
Application Number:	13/683,236
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,846,112
Patent Claims:	1. A method of providing pharmaceutically acceptable nitric oxide gas, the method comprising: obtaining a cylinder containing compressed nitric oxide gas in the form of a gaseous blend of nitric oxide and nitrogen; supplying the cylinder containing compressed nitric oxide gas to a medical provider responsible for treating neonates who have hypoxic respiratory failure, including some who do not have left ventricular dysfunction; providing to the medical provider (i) information that a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure is 20 ppm nitric oxide and (ii) information that, in patients with pre-existing left ventricular dysfunction, inhaled nitric oxide may increase pulmonary capillary wedge pressure (PCWP), leading to pulmonary edema, the information of (ii) being sufficient to cause a medical provider considering inhaled nitric oxide treatment for a plurality of neonatal patients who (a) are suffering from a condition for which inhaled nitric oxide is indicated, and (b) have pre-existing left ventricular dysfunction, to elect to avoid treating one or more of the plurality of patients with inhaled nitric oxide in order to avoid putting the one or more patients at risk of pulmonary edema. 2. The method of claim 1, wherein the information of (i) and the information of (ii) appear in prescribing information supplied to the medical provider with the cylinder containing compressed nitric oxide gas. 3. The method of claim 1, further comprising: performing at least one diagnostic process to identify a first neonatal patient who has hypoxic respiratory failure and is a candidate for 20 ppm inhaled nitric oxide treatment; determining that the first neonatal patient has pre-existing left ventricular dysfunction; evaluating the potential benefit of treating the first neonatal patient with 20 ppm inhaled nitric oxide vs. the potential risk that inhaled nitric oxide could cause an increase in PCWP leading to pulmonary edema in patients who have pre-existing left ventricular dysfunction, in order to arrive at a decision of whether or not to treat the first neonatal patient with inhaled nitric oxide; identifying a second neonatal patient as having hypoxic respiratory failure and not having left ventricular dysfunction; and treating the second neonatal patient with 20 ppm inhaled nitric oxide. 4. The method of claim 1, further comprising: performing at least one diagnostic process to identify a plurality of neonatal patients who have hypoxic respiratory failure and are candidates for inhaled nitric oxide treatment; determining prior to treatment with inhaled nitric oxide whether or not each patient of the plurality has pre-existing left ventricular dysfunction; determining that a first patient of the plurality does not have pre-existing left ventricular dysfunction; treating the first patient with 20 ppm inhaled nitric oxide; determining that other patients of the plurality do have pre-existing left ventricular dysfunction; for each patient of the plurality determined to have pre-existing left ventricular dysfunction, evaluating on a case-by-case basis the potential benefit of treating the patient with 20 ppm inhaled nitric oxide vs. the potential risk that inhaled nitric oxide could cause an increase in PCWP, leading to pulmonary edema; for at least one patient of the plurality determined to have pre-existing left ventricular dysfunction, determining that the potential benefit of the treatment outweighs the potential risk described in the second warning; and treating the at least one patient with 20 ppm inhaled nitric oxide. 5. The method of claim 3, wherein the information of (i) and the information of (ii) appear in prescribing information supplied to the medical provider with the cylinder containing compressed nitric oxide gas. 6. The method of claim 4, wherein the information of (i) and the information of (ii) appear in prescribing information supplied to the medical provider with the cylinder containing compressed nitric oxide gas. 7. A method of providing pharmaceutically acceptable nitric oxide gas, the method comprising: obtaining a cylinder containing compressed nitric oxide gas in the form of a gaseous blend of nitric oxide and nitrogen; supplying the cylinder containing compressed nitric oxide gas to a medical provider responsible for treating neonates who have hypoxic respiratory failure, including some who do not have pre-existing left ventricular dysfunction; and providing to the medical provider (i) information that a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure is 20 ppm nitric oxide, (ii) information that patients who have pre-existing left ventricular dysfunction and are treated with inhaled nitric oxide may experience pulmonary edema, and (iii) a recommendation that, if pulmonary edema occurs in a patient who has pre-existing left ventricular dysfunction and is treated with inhaled nitric oxide, the treatment with inhaled nitric oxide should be discontinued. 8. The method of claim 7, wherein the information of (i) and (ii) and the recommendation of (iii) appear in prescribing information supplied to the medical provider with the cylinder containing compressed nitric oxide gas. 9. The method of claim 7, further comprising: performing at least one diagnostic process to identify a neonatal patient who has hypoxic respiratory failure and is a candidate for inhaled nitric oxide treatment; determining prior to treatment with inhaled nitric oxide that the neonatal patient has pre-existing left ventricular dysfunction; treating the neonatal patient with 20 ppm inhaled nitric oxide, whereupon the neonatal patient experiences pulmonary edema; and in accordance with the recommendation of (iii), discontinuing the treatment with inhaled nitric oxide due to the neonatal patient's pulmonary edema. 10. The method of claim 4, wherein the at least one patient is monitored for evidence of increased PCWP and/or for evidence of pulmonary edema during treatment with 20 ppm inhaled nitric oxide. 11. The method of claim 9, wherein the neonatal patient is monitored for evidence of increased PCWP and/or for evidence of pulmonary edema during treatment with 20 ppm inhaled nitric oxide. 12. A method comprising: obtaining a source of nitric oxide gas comprising a cylinder of compressed gas and/or a device that delivers nitric oxide gas into an inspiratory limb of a breathing circuit, for inhalation by a patient; supplying the source of nitric oxide gas to a medical provider responsible for treating neonates who have hypoxic respiratory failure, including some who do not have left ventricular dysfunction; and providing to the medical provider (i) information that a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure is 20 ppm nitric oxide and (ii) information that, in patients with pre-existing left ventricular dysfunction, inhaled nitric oxide may increase PCWP, leading to pulmonary edema, the information of (ii) being sufficient to cause a medical provider considering inhaled nitric oxide treatment for a plurality of neonatal patients who (a) are suffering from a condition for which inhaled nitric oxide is indicated, and (b) have pre-existing left ventricular dysfunction, to elect to avoid treating one or more of the plurality of patients with inhaled nitric oxide in order to avoid putting the one or more patients at risk of pulmonary edema. 13. The method of claim 12, wherein the information of (i) and the information of (ii) appear in prescribing information supplied to the medical provider with the source of nitric oxide gas. 14. A method comprising: obtaining a device that delivers nitric oxide gas into an inspiratory limb of a breathing circuit, for inhalation by a patient; supplying the device to a medical provider responsible for treating neonates who have hypoxic respiratory failure, including some who do not have pre-existing left ventricular dysfunction; providing to the medical provider (i) information that a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure is 20 ppm nitric oxide and (ii) information that, in patients with pre-existing left ventricular dysfunction, inhaled nitric oxide may increase PCWP, leading to pulmonary edema, the information of (ii) being sufficient to cause a medical provider considering inhaled nitric oxide treatment for multiple neonatal patients who (a) are suffering from hypoxic respiratory failure, and (b) have pre-existing left ventricular dysfunction, to elect to avoid treating one or more of the multiple patients with inhaled nitric oxide in order to avoid putting the one or more patients at risk of pulmonary edema. 15. The method of claim 14, wherein the information of (i) and the information of (ii) appear in prescribing information supplied to the medical provider with the device. 16. The method of claim 12, further comprising: identifying a first neonatal patient who has hypoxic respiratory failure and is a candidate for 20 ppm inhaled nitric oxide treatment; determining that the first neonatal patient has pre-existing left ventricular dysfunction; evaluating the potential benefit of treating the first neonatal patient with 20 ppm inhaled nitric oxide vs. the potential risk described in the information of (ii) that inhaled nitric oxide could cause an increase in PCWP leading to pulmonary edema in patients who have pre-existing left ventricular dysfunction, in order to arrive at a decision of whether or not to treat the first neonatal patient with inhaled nitric oxide; identifying a second neonatal patient as having hypoxic respiratory failure and not having left ventricular dysfunction; and using the source of nitric oxide gas to treat the second neonatal patient with 20 ppm inhaled nitric oxide. 17. The method of claim 12, further comprising: identifying a plurality of neonatal hypoxic respiratory failure patients who are candidates for inhaled nitric oxide treatment; determining prior to treatment with inhaled nitric oxide whether or not each patient of the plurality has pre-existing left ventricular dysfunction, thereby determining that a first patient of the plurality does not have pre-existing left ventricular dysfunction; using the source of nitric oxide gas to treat the first patient with 20 ppm inhaled nitric oxide; determining that other patients of the plurality do have pre-existing left ventricular dysfunction; for each patient of the plurality who is determined to have pre-existing left ventricular dysfunction, evaluating on a case-by-case basis the potential benefit of treating the patient with 20 ppm inhaled nitric oxide vs. the potential risk described in the information of (ii) that inhaled nitric oxide could cause an increase in PCWP, leading to pulmonary edema; for at least one of the evaluated patients, determining that the potential benefit of the treatment outweighs the potential risk; and using the source of nitric oxide gas to treat the at least one patient with 20 ppm inhaled nitric oxide. 18. The method of claim 14, further comprising: identifying a first neonatal patient who has hypoxic respiratory failure and is a candidate for 20 ppm inhaled nitric oxide treatment; determining that the first neonatal patient has pre-existing left ventricular dysfunction; evaluating the potential benefit of treating the first neonatal patient with 20 ppm inhaled nitric oxide vs. the potential risk described in the information of (ii) that inhaled nitric oxide could cause an increase in PCWP leading to pulmonary edema in patients who have pre-existing left ventricular dysfunction, in order to arrive at a decision of whether or not to treat the first neonatal patient with inhaled nitric oxide; identifying a second neonatal patient as having hypoxic respiratory failure and not having left ventricular dysfunction; and using the device to treat the second neonatal patient with 20 ppm inhaled nitric oxide. 19. The method of claim 14, further comprising: identifying a plurality of neonatal hypoxic respiratory failure patients who are candidates for inhaled nitric oxide treatment; determining, prior to treatment with inhaled nitric oxide, whether or not each patient of the plurality has pre-existing left ventricular dysfunction, thereby determining that a first patient of the plurality does not have pre-existing left ventricular dysfunction; using the device to treat the first patient with 20 ppm inhaled nitric oxide; determining that other patients of the plurality do have pre-existing left ventricular dysfunction; for each patient of the plurality who is determined to have pre-existing left ventricular dysfunction, evaluating on a case-by-case basis the potential benefit of treating the patient with 20 ppm inhaled nitric oxide vs. the potential risk described in the information of (ii) that inhaled nitric oxide could cause an increase in PCWP, leading to pulmonary edema; for at least one of the evaluated patients, determining that the potential benefit of the treatment outweighs the potential risk; and using the device to treat the at least one patient with 20 ppm inhaled nitric oxide.