A method for maintaining a therapeutically effective concentration of endoxifen for the treatment of patient with bipolar I disorder is provided. The method includes administering to the patient a dose of 2 mg to 16 mg of endoxifen citrate in an enteric coated tablet once per day for at least 21 days. Further, the said method provides a desirable in-vivo plasma profile. The therapeutic dose monitoring is not required in a patient undergoing the said treatment. Furthermore, the method provides a significant improvement in mania assessed by the YMRS and the MADRS scores in patient undergoing the said treatment. Furthermore, the method as provides an early response time of the treatment in at least 2 days and remission time that is not more than 4 days in patient undergoing the said treatment.

A method for maintaining a therapeutically effective concentration of endoxifen for treatment of a patient with bipolar I disorder is provided. The said method includes administering to the patient, a dose of 2 mg to 16 mg of endoxifen citrate in an enteric coated tablet once per day for at least 21 days. Further, the patient is not required to be administered rescue medication during the administration of the endoxifen citrate.

A method for maintaining a therapeutically effective concentration of endoxifen for the treatment of patient with bipolar I disorder is provided. The method includes administering to the patient a dose of 2 mg to 16 mg of endoxifen citrate in an enteric coated tablet once per day for at least 21 days. Further, the said method provides a desirable in-vivo plasma profile. The therapeutic dose monitoring is not required in a patient undergoing the said treatment. Furthermore, the method provides a significant improvement in mania assessed by the YMRS and the MADRS scores in patient undergoing the said treatment. Furthermore, the method as provides an early response time of the treatment in at least 2 days and remission time that is not more than 4 days in patient undergoing the said treatment.

A method for managing or decreasing a risk of suicidal behaviour in a patient undergoing treatment of bipolar I disorder is provided. The said method includes maintaining the therapeutically effective concentration of endoxifen by administrating a dose of 2 mg to 16 mg of endoxifen citrate in an enteric coated tablet once per day for at least 21 days.

Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

The present invention contemplates a method of treating a solid cancerous tumor in a mammalian subject by the oral administration of a solid cancerous tumor-effective amount of a halogenated xanthene (HX), the lactone thereof, a pharmaceutically acceptable salt, or a C.sub.1-C.sub.4 alkyl or aromatic ester thereof (collectively an HX compound) to that mammalian subject, and liquid and solid pharmaceutical compositions for administering the HX compound. In addition, a method of inhibiting the growth of a GI tract carcinoma of a mammalian subject by the oral administration of a solid cancerous tumor-effective amount of an HX compound, as well as solid and liquid pharmaceutical compositions therefor.

A method for treating a viral infection of a mammalian subject that comprises administering a virus-inhibiting amount of a halogenated xanthene, a pharmaceutically acceptable salt, an alkyl ester or amide or aromatic ester or amide derivative thereof as disclosed within, to that mammalian subject. A method of inducing a type I interferon response in a mammalian subject that presents with a microbial infection, cancerous tumor or hematological malignancy that comprises administering an amount of a halogenated xanthene as discussed above, effective to induce the type I interferon response. A method of enhancing a mammalian immunogen-specific immune response that comprises contacting mammalian cells, in vivo or present in a mammalian cell growth supporting medium, with an adjuvant-effective amount of a halogenated xanthene as discussed above, and an immunogen to which that response is to be enhanced.

Dosage forms containing nefopam, nefopam metabolite, nefopam prodrug, isomers thereof or combinations of the foregoing, optionally an acid, and optionally an opioid analgesic and/or NSAID, and associated methods for treating various types of pain in patients.

Dosage forms containing nefopam, nefopam metabolite, nefopam prodrug, isomers thereof or combinations of the foregoing, optionally an acid, and optionally an opioid analgesic and/or NSAID, and associated methods for treating various types of pain in patients.

The present disclosure provides crystalline forms of tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine (A2-73), in freebase or salt forms. Also described are pharmaceutical formulations and dosage forms comprising the disclosed crystal forms, and methods of using crystalline A2-73 in dosage forms for neuroprotection including treatment of neurodegenerative and other diseases.