TOPICAL REGIONAL NEURO-AFFECTIVE THERAPY
A method of treating a disease state or condition in humans via topical brainstem afferent stimulation therapy via the administration of a drug to the back of the neck of a human patient at the hairline in close proximity to and under or on the area of skin above the brain stem to provide regional neuro-affective therapy is disclosed.
1 : A method of treating pain in a human patient, comprising administering a drug for the treatment of neuropathic and/or, neurogenic pain which is an opioid analgesic in a therapeutically effective amount to treat the disease state or condition, to the back of the neck at the hairline in close proximity to and under or on the area of skin above the brain stem to provide regional neuro-affective therapy to the human patient.
2 : The method of claim 1 , wherein the drug is selected from the group consisting of morphine, codeine, dihydrocodeine, hydrocodone, hydromorphone, nicomorphine, oxycodone, oxymorphone, fentanyl, alphamethylfentanyl, alfentanil, sufentanil, remifentanil, carfentanyl, ohmefentanyl, thebaine, oripavine, diacetylmorphine (heroin), phenylpiperidines such as pethidine (meperidine) and ketobemidone, allylprodine, prodine, propoxyphene, dextropropoxyphene, dextromoramide, bezitramide, piritramide, methadone, dipipanone, levomethadyl Acetate (LAAM), loperamide, diphenoxylate, dezocine, pentazocine, phenazocine, buprenorphine, dihydroetorphine, etorphine, butorphanol, nalbuphine, levorphanol, levomethorphan, lefetamine, meptazinol, tilidine, tramadol, tapentadol, and mixtures thereof.
3 . (canceled)
4 : The method of claim 2 , wherein the drug is selected from the group consisting of morphine, codeine, dihydrocodeine, hydrocodone, hydromorphone, oxycodone, oxymorphone, fentanyl, sufentanil, tramadol, and mixtures thereof.
5 : The method of claim 2 , diseases wherein the drug comprises morphine.
6 - 11 . (canceled)
12 : The method of claim 1 , wherein the drug is used in the treatment of neuropathic and/or neurogenic pain.
13 - 24 . (canceled)
25 : The method of claim 1 , wherein the drug is formulated in a pharmaceutically acceptable immediate release topical carrier.
26 : The method of claim 25 , wherein the carrier is aqueous-based.
27 : The method of claim 1 , further comprising formulating the drug in a pharmaceutically acceptable immediate release aqueous-based carrier, and applying a sufficient amount to the back of the neck at the hairline (“BONATH”) of the human patient such that the onset of clinical effect occurs in less than about 30 minutes.
28 . (canceled)
29 : The method of claim 27 , 25 , wherein the carrier is a gel or cream.
30 : The method of claim 29 , further comprising adding at least one adjuvant selected from the group consisting of a penetration enhancer, antioxidant, stabilizer, and mixtures thereof to the carrier.
31 : The method of claim 1 , wherein the drug is incorporated into a sustained release transdermal delivery system which is capable of delivering the drug through the skin of a human patient over a 24 hour period, the transdermal delivery system being capable of delivering the drug in such amounts for a time period from about 1 to about 7 days.
32 : The method of claim 31 , wherein the transdermal delivery system is selected from the group consisting of a transdermal patch, a transdermal plaster, a transdermal disc, and an iontophoretic transdermal device.
33 - 34 . (canceled)
35 : The method of claim 1 , wherein the drug is administered via injection in an immediate release pharmaceutically acceptable carrier for injection.
36 : The method of claim 1 , wherein the drug is administered via injection or implantation in a controlled release carrier to provide a prolonged effect of the drug.
37 : The method of claim 1 , wherein the drug is incorporated into a delivery system selected from the group consisting of a gel, a matrix, microparticles, a pellet, an insert, a colloidal material, and mixtures of any of the foregoing.
38 - 51 . (canceled)
52 : A method for treating neuropathic and/or neurogenic pain in a human patient, comprising topically administering an opioid analgesic in an immediate release topical formulation at the back of the neck to provide treatment of neuropathic and/or neurogenic pain in the human patient in less than about 30 minutes after said topical administration.
53 : The method of claim 52 , wherein the drug is selected from the group consisting of morphine, codeine, dihydrocodeine, hydrocodone, hydromorphone, oxycodone, oxymorphone, fentanyl, sufentanil, tramadol, and mixtures thereof.
54 : The method of claim 52 , wherein the drug comprises morphine.
55 : The method of claim 52 , wherein the drug comprises tramadol.
56 : The method of claim 52 , wherein the topical formulation is applied in the form of a cream or gel.