NOVEL COMPOSITIONS AND METHODS

1 . A transdermal pharmaceutical formulation comprising 1-(4-fluoro-phenyl)-4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′: 4 , 5 ]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one (Compound of Formula I) in free base form;

wherein the formulation is comprised in an adhesive patch; and wherein the formulation comprises an adhesive polymer;

wherein the formulation further comprises one or more excipients selected from lauryl lactate, isopropyl myristate, oleayl oleate, methyl laurate, isopropyl palmitate, and ethyl oleate.

2 . (canceled)

3 . (canceled)

4 . (canceled)

5 . The formulation of claim 1 , wherein the formulation comprises from 1 to 1000 mg of the Compound of Formula I in free base form.

6 . The formulation of claim 1 , further comprising one or more excipients selected from the group consisting of solvents, solubilizers, plasticizers, surfactants, binders, humectants, antioxidants, buffering agents.

7 . The formulation of claim 6 , wherein the one or more excipients are selected from any of the following: alcohols, non-alcoholic solvents, gums, polysaccharides and polysaccharide derivatives, gelatins polyvinylpyrrolidones, polyethylene oxide and/or polypropylene oxide polymers and copolymers, polyacrylate polymers, polyamide polymers, sugars and sugar alcohols, polypeptides/proteins, amino acids, inorganic or organic acids and their salts and esters, inorganic or organic bases, anionic surfactants, cationic surfactants, zwitterionic surfactants, nonionic surfactants, sorbitan esters, polyethoxylated sorbitan esters, fatty acid esters, fatty alcohols, and antioxidants.

8 . The formulation of claim 1 , wherein the formulation comprises the adhesive polymer in an amount from 25-80% by weight.

9 . The formulation of claim 8 , wherein the adhesive polymer comprises a polymer selected from the group consisting of acrylate polymers or co-polymers; polyvinylpyrrolidones, copolymers of maleic acid or a maleic ester with a vinyl ether, cellulose derivatives, silicone polymers, and mixtures thereof.

10 . The formulation of claim 1 , wherein the formulation further comprises either dimethyldodecyl amine oxide or lactic acid.

11 . The formulation of claim 1 , wherein the formulation further comprises propylene glycol.

12 . The formulation of claim 9 , wherein the adhesive polymer comprises a mixture of a polyacrylate polymer and a silicone polymer.

13 . A transdermal pharmaceutical device comprising the formulation according to claim 1 , wherein the device comprises at least two layers, wherein at least one layer is a drug reservoir layer, and at least one layer is a backing layer, and wherein the drug reservoir layer comprises said formulation.

14 . The device of claim 13 , wherein the drug reservoir layer is the skin-contacting layer of the device.

15 . The device of claim 13 , wherein the device further comprises a third layer, separate from the drug reservoir layer, which third layer is the skin-contacting layer and which layer comprises an adhesive polymer, and which layer is substantially free of the Compound of Formula I prior to use of the device.

16 . The device of claim 15 , wherein the device further comprises an intermediate layer disposed between the skin contact layer and the drug reservoir layer, which layer is a rate-control layer.

17 . The device of claim 13 , wherein the skin-contacting layer comprise one or more excipients selected from lauryl lactate, isopropyl myristate, oleayl oleate, methyl laurate, isopropyl palmitate, and ethyl oleate.

18 . The device of claim 13 , wherein the device comprises from 1 to 1000 mg of the Compound of Formula I in free base form.

19 . The device of claim 13 , wherein the device is formulated to deliver the Compound of Formula I to a patient over a period of time from 1 to 30 days.

20 . The device of claim 13 , wherein the device is formulated to deliver the Compound of Formula I to a patient at an average daily dosage of from 1 to 60 mg per day (free base equivalent).

21 . The device of claim 13 , wherein the device systemically delivers a mean daily dose of the compound of Formula I of 0.1 to 5.0 mg per day (free base equivalent).

22 . The device of claim 13 , wherein the device delivers the compound of Formula I or the Compound of Formula II or the Compound of Formula III at a rate sufficient to maintain a steady state maximum plasma concentration of the compound (free base) of 5 to 50 ng/mL and/or sufficient to maintain a steady state 24-hour mean plasma concentration area under the curve (AUC) of the compound (free base) of 5 to 100 ng-hr/mL.

23 . A method for the prophylaxis or treatment of a disease or abnormal condition involving or mediated by the 5-HT 2A receptor, serotonin transporter (SERT), and/or dopamine D 1 /D 2 receptor signaling pathways, in a patient in need thereof, comprising administering to the patient by a transdermal route, a therapeutically effective amount of the Compound of Formula I by administering to said patient the formulation according to claim 1 .

24 . (canceled)

25 . (canceled)

26 . The method according to claim 23 , wherein the disease or condition is selected from obesity, anorexia, bulimia, depression, anxiety, psychosis, schizophrenia, obsessive-compulsive disorder, sexual disorders, migraine, attention deficit disorder, attention deficit hyperactivity disorder, sleep disorders, conditions associated with cephalic pain, social phobias, dementia bipolar disorder, and bipolar depression.

27 . A method for the prophylaxis or treatment of a disease or abnormal condition involving or mediated by the 5-HT 2A receptor, serotonin transporter (SERT), and/or dopamine D 1 /D 2 receptor signaling pathways, in a patient in need thereof, comprising administering to the patient by a transdermal route, a therapeutically effective amount of Compound of Formula I by administering to said patient the device according to claim 12 .

28 . The method according to claim 27 , wherein the disease or condition is selected from obesity, anorexia, bulimia, depression, anxiety, psychosis, schizophrenia, obsessive-compulsive disorder, sexual disorders, migraine, attention deficit disorder, attention deficit hyperactivity disorder, sleep disorders, conditions associated with cephalic pain, social phobias, dementia, bipolar disorder, and bipolar depression.

29 . The formulation of claim 1 , wherein the one or more excipients are selected from lauryl lactate and methyl laurate.

30 . The formulation of claim 7 , wherein the one or more excipients are selected from any of the following: ethanol, isopropanol, propanol, glycerol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, polyethylene glycol, dimethylsulfoxide, dimethylformamide, acetonitrile, acacia gum, guar gum, agar, xanthan gum, tragacanth gum, karaya gum, gellan gum, starches, dextrans, pectins, alginates, carrageenans, cellulose, cellulose derivatives, bovine gelatins, porcine gelatins, avian gelatins, fish gelatins, poloxamers, carbopols, dextrose, lactose, galactose, glucose, ribose, sucrose, trehalose, mannitol, maltitol, lactitol, sorbitol, xylitol, erythritol, galactitol, inositol;

benzoic acid, toluenesulfonic acid, phosphoric acid, sulfuric acid, hydrochloric acid, tartaric acid, oxalic acid, cyclamic acid, ascorbic acid, methanesulfonic acid, benzenesulfonic acid, formic acid or their sodium, potassium, calcium, magnesium, lithium, ammonium salts; sodium lauryl sulfate, sodium laureth sulfate, sodium dodecylbenzenesulfonate, sodium lauroyl sarcosinate, sodium stearate, benzalkonium halides, cetylpyridinium halides, cetrimonium halides, benzethonium halides, cocamidopropyl betaine, polyethylene glycol polydodecyl ethers, sorbitan monolaurate, sorbitan monooleate, sorbitan monopalmitate, sorbitan monostearate, sorbitan tristearate, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, dodecanol, octyldecanol, lauryl alcohol, ascorbic acid, citric acid, ascorbyl palmitate, sodium metabisulfite, BHT, BHA, TBHQ, propyl gallate, beta-carotene, tocopherols, and tocotrienols.

31 . The formulation of claim 28 , wherein the cellulose derivatives are selected from carboxymethyl cellulose, methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, and hydroxypropyl methyl cellulose.

32 . The formulation of claim 9 , wherein the adhesive polymer comprises a polymer selected from the group consisting of acrylate polymers or co-polymers, linear polyvinylpyrrolidones, cross-linked polyvinylpyrrolidones, copolymers of maleic acid or anhydride with methyl vinyl ether, carboxymethyl cellulose, dimethylsilicone, and mixtures thereof.

33 . The formulation of claim 1 , wherein the formulation comprises about 10% w/w of the Compound of Formula I, and about 1% w/w of propylene glycol.

34 . The formulation of claim 1 , wherein the formulation comprises about 10% w/w of the Compound of Formula I, about 5% w/w of propylene glycol, about 5% by weight of lauryl lactate, about 5% w/w of methyl laurate, and about 5% w/w of propylene glycol dicaprate/dicaproate.

35 . The formulation of claim 1 , wherein the formulation comprises about 20% w/w of the Compound of Formula I, about 10% w/w of propylene glycol, about 15% w/w of lauryl lactate, and about 2% w/w of dimethyldodecylamine oxide.

36 . The formulation of claim 1 , wherein the formulation comprises about 20% w/w of the Compound of Formula I, about 10% w/w of propylene glycol, about 14% w/w of lauryl lactate, about 1% lactic acid, and about 0-3% w/w dimethyldodecylamine oxide.

37 . The formulation of claim 36 , wherein the formulation comprises 2% or 3% w/w dimethyldodecylamine oxide.