<SEC-DOCUMENT>0001387131-13-002200.txt : 20130614
<SEC-HEADER>0001387131-13-002200.hdr.sgml : 20130614
<ACCEPTANCE-DATETIME>20130614080453
ACCESSION NUMBER:		0001387131-13-002200
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20130611
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20130614
DATE AS OF CHANGE:		20130614

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			TherapeuticsMD, Inc.
		CENTRAL INDEX KEY:			0000025743
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				870233535
		STATE OF INCORPORATION:			NV
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-00100
		FILM NUMBER:		13912842

	BUSINESS ADDRESS:	
		STREET 1:		951 BROKEN SOUND PARKWAY NW
		STREET 2:		SUITE 320
		CITY:			BOCA RATON
		STATE:			FL
		ZIP:			33487
		BUSINESS PHONE:		561-961-1911

	MAIL ADDRESS:	
		STREET 1:		951 BROKEN SOUND PARKWAY NW
		STREET 2:		SUITE 320
		CITY:			BOCA RATON
		STATE:			FL
		ZIP:			33487

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AMHN, Inc.
		DATE OF NAME CHANGE:	20090930

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	CROFF ENTERPRISES INC
		DATE OF NAME CHANGE:	19970915

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	CROFF OIL CO
		DATE OF NAME CHANGE:	19920703
</SEC-HEADER>
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<TYPE>8-K
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<FILENAME>txmd-8k_061113.htm
<DESCRIPTION>CURRENT REPORT
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; TEXT-DECORATION: underline">SECTION 7 &#8211; REGULATION FD</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Item 7.01.&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;Regulation FD Disclosure</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font id="TAB1" style="MARGIN-LEFT: 42pt"></font>On June 11, 2013, TherapeuticsMD&#8482;, Inc., ("TherapeuticsMD" or the "Company"), received acceptance from the U.S. Food and Drug Administration ("FDA") for its Investigational New Drug ("IND") application for TX12-004HR, a vaginal estradiol suppository. TherapeuticsMD is developing TX12-004HR for vulvar and vaginal atrophy (VVA), a thinning of the vaginal walls that occurs as estrogen levels drop during menopause.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font id="TAB1" style="MARGIN-LEFT: 42pt"></font>The Company issued a press release announcing the FDA acceptance of the IND for TX12-004HR on June 14, 2013, a copy of which is attached as Exhibit 99.1 hereto.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font id="TAB1" style="MARGIN-LEFT: 42pt"></font>The information in this Item 7.01 of this Form 8-K, including the exhibit (the "Report"), is furnished pursuant to Item 7.01 and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 (the "Act"), or otherwise subject to the liabilities of that section. This Report also shall not be deemed to be incorporated by reference into any filing under the Act except to the extent that the Company specifically incorporates it by reference.<font style="DISPLAY: inline; FONT-SIZE: 10pt">&#160;</font>This Report will not be deemed an admission as to the materiality of any information in the Report that is required to be disclosed solely by Regulation FD.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font id="TAB1" style="MARGIN-LEFT: 42pt"></font>The text included with this Report on Form 8-K is available on the Company&#8217;s website located at <font style="FONT-STYLE: italic; DISPLAY: inline">www.therapeuticsmd.com</font>, although the Company reserves the right to discontinue that availability at any time.</font></div>

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<font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">(d)&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;Exhibits:</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">June 14, 2012</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><a href="ex99-1.htm">Press Release from TherapeuticsMD, Inc., dated June 14, 2013, entitled &#8220;TherapeuticsMD Investigational New Drug Filing Accepted by FDA&#8221;</a></font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">THERAPEUTICSMD, INC.</font></font></div>
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<td valign="bottom" width="37%"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">Date: <font style="DISPLAY: inline; TEXT-DECORATION: underline">June 14, 2013</font>&#160;&#160;&#160;&#160;</font></font></td>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">/s/ Robert G. Finizio</font></div>
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<td valign="bottom" width="32%"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">Robert G. Finizio, Chief Executive Officer</font></td>
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<div><a href="txmd-8k_061113.htm">TherapeuticsMD 8-K</a></div>

<div>&#160;</div>

<div>Exhibit 99.1</div>

<div>&#160;</div>

<div align="center">
<table bgcolor="white" cellpadding="0" cellspacing="0" width="100%" style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">
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<td valign="bottom" width="32%"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">&#160; </font></td>
<td width="33%"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">&#160;</font></td>
<td width="35%"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><img src="txmd-logo.jpg" alt=""></font></td>
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<td width="32%"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Contacts:</font></font></font></td>
<td width="33%"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">&#160;</font></td>
<td width="35%"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">&#160;</font></td>
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<div><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">Dan Cartwright&#160;&#160;</font></div>

<div>Chief Financial Officer&#160;&#160;</div>

<div>Tel: (561) 961-1930</div>

<div>
<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; COLOR: #0000ff; FONT-SIZE: 10pt; TEXT-DECORATION: underline">Dan.Cartwright@TherapeuticsMD.com</font></font></div>
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<td width="33%"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">&#160;</font></td>
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<div><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">Investor Relations:</font></div>

<div><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">Lisa M. Wilson</font></div>

<div><font style="DISPLAY: inline">In-Site Communications</font></div>

<div><font style="DISPLAY: inline">Tel: (917) 543-993</font></div>

<div>
<div style="TEXT-ALIGN: left; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; COLOR: #0000ff; TEXT-DECORATION: underline">lwilson@insitecony.com</font></font></div>
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<div>&#160;</div>

<div>
<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">THERAPEUTICSMD INVESTIGATIONAL NEW DRUG FILING ACCEPTED BY FDA</font><br>
&#160;</div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Boca Raton, FL,</font><font style="DISPLAY: inline">&#160;</font><font style="DISPLAY: inline; FONT-WEIGHT: bold">June 14, 2013 &#8211; </font>TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women&#8217;s healthcare company focused on developing and commercializing products targeted exclusively for women, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for TX12-004HR, a vaginal estradiol suppository. TherapeuticsMD is developing TX12-004HR for vulvar and vaginal atrophy (VVA), a thinning of the vaginal walls that occurs as estrogen levels drop during menopause. The acceptance of the IND will allow the Company to begin clinical trials.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block"><br>
</div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Julia Amadio, Chief Product Officer stated, &#8220;We are very excited to move forward with testing this simple, novel delivery of vaginal estradiol for vulvar and vaginal atrophic symptoms in postmenopausal women. We believe that there is a large and growing unmet need for this product as women will continue to develop vaginal atrophy after menopause without therapy.&#8221;</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">About Vulvar and Vaginal Atrophy</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block"><br>
</div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">For many women going through menopause, the loss of estrogen can result in less vaginal lubrication; thinner, drier vaginal walls and less elastic vaginal tissue. This can cause some very uncomfortable physical symptoms, including: painful intercourse; and drying, burning and itching in and around the vagina.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">About TherapeuticsMD, Inc.</font></font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block"><br>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">TherapeuticsMD, Inc. is a women&#8217;s health pharmaceutical company driven to pursue the development and commercialization of advanced hormone replacement therapies. We are currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. We are evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure. More information is available at <font style="DISPLAY: inline; COLOR: #0000ff; TEXT-DECORATION: underline">www.therapeuticsmd.com</font>.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block"><br>
</div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">TherapeuticsMD<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#174;</font> is a registered trademark.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block"><br>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company&#8217;s expectation that it will move forward with testing TX12-004HR, and the Company&#8217;s beliefs that TX12-004HR represents a simple, novel delivery of vaginal estradiol for vulvar and vaginal atrophic symptoms in postmenopausal women and that there is a large and growing unmet need for this product as women will continue to develop vaginal atrophy after menopause without therapy, are forward-looking statements within the meaning of the &#8220;safe harbor&#8221; provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: the Company&#8217;s ability to obtain adequate funding for its clinical trials; timely and successful completion of clinical studies and the results thereof; developments in the women&#8217;s healthcare industry; the risks and uncertainties associated with economic and market conditions; risks and uncertainties associated with TherapeuticsMD&#8217;s business and finances in general; and other risks detailed in TherapeuticsMD&#8217;s filings with the U.S. Securities and Exchange Commission including its annual report on Form 10-K filed on March 12, 2013, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and TherapeuticsMD undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#160;</div>

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`
end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
